xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05985083</url>
    </required_header>
    <id_info>
      <org_study_id>IMM47-201</org_study_id>
      <nct_id>NCT05985083</nct_id>
    </id_info>
    <brief_title>A Study Of IMM47 In Subjects With Advanced Solid Tumors</brief_title>
    <official_title>A Phase I, Open-Label, Multicenter, Dose-Escalation And Cohort-Expansion Study Of IMM47 In Subjects With Advanced Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ImmuneOnco Biopharmaceuticals (Shanghai) Inc.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>IQVIA RDS</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>ImmuneOnco Biopharmaceuticals (Shanghai) Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a first-in-human (FIH), open-label, multi-center, phase I study to evaluate the&#xD;
        safety, tolerance, pharmacokinetics (PK), immunogenicity, preliminary anti-tumor activity,&#xD;
        pharmacodynamics, and biomarker activity of IMM47 monotherapy in subjects with advanced solid&#xD;
        tumors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In phase Ia phase, approximately 17-48 eligible subjects with advanced solid tumors will be&#xD;
        enrolled, and an accelerated titration method and the traditional &quot;3+3&quot; design method will be&#xD;
        adopted to explore the safety, tolerability, PK, immunogenicity, and anti-tumor activity of 6&#xD;
        dose levels of IMM47: 5 μg/kg, 50 μg/kg, 250 μg/kg, 1.0 mg/kg, 3.0 mg/kg and 5.0 mg/kg or&#xD;
        higher, to determine the MTD and RP2D.&#xD;
  &#xD;
        Accelerated dose cohorts: At the dose cohorts of 5 μg/kg and 50 μg/kg, one subject will be&#xD;
        enrolled at first, and the conventional &quot;3+3&quot; design will be altered and the additional 2 or&#xD;
        5 subjects would be enrolled if any ≥ Grade 2 drug related toxicities are observed during the&#xD;
        first 28-day cycle (DLT observational period).&#xD;
  &#xD;
        &quot;3+3&quot; dose cohorts: Thereafter, at least three subjects will be enrolled in each dose cohort&#xD;
        at the 250 μg/kg, 1.0 mg/kg, 3.0 mg/kg and 5.0 mg/kg dose levels sequentially. There will be&#xD;
        a minimum interval of 48 hours between the 1st and 2nd subjects being dosed in each &quot;3+3&quot;&#xD;
        dose cohort. If no DLTs occur in a dose cohort of 3 subjects during the first cycle (DLT&#xD;
        observational period), 3 subjects will be enrolled at the next higher dose level. If 1 of 3&#xD;
        subjects in a cohort experiences a DLT, an additional 3 subjects will be enrolled at that&#xD;
        dose level. If only 1 of 6 subjects experiences a DLT, then 3 subjects will be enrolled at&#xD;
        the next higher dose level. If 2 or more subjects experienced DLTs within a cohort, dose&#xD;
        escalation will be halted and 3 more subjects will be enrolled at the previous lower&#xD;
        (tolerated) dose level until that cohort has 6 evaluable subjects. Depending on toxicity, the&#xD;
        dose deescalation to an intermediate dose may occur. Higher doses than 5.0 mg/kg may be&#xD;
        explored under the decision of Safety Review Committee (SRC). A total of 6 subjects must be&#xD;
        enrolled at the MTD (or the highest dose studied where no more than 1 of 6 subjects&#xD;
        experiences a DLT if the MTD is not identified) and evaluated at the end of Cycle 1 before&#xD;
        any subject is dosed in the expansion cohorts.&#xD;
  &#xD;
        Continued dosing with IMM47 beyond the second cycle will be offered to subjects who do not&#xD;
        experience disease progression or significant toxicity. Subjects who are benefiting from&#xD;
        IMM47 will receive the treatment up to 12 cycles, at investigator's discretion. Subjects&#xD;
        discontinuing the study treatment early for any reason will complete an end-of-treatment&#xD;
        (EOT) visit within 30 (+7) days after the last dose, and a safety follow-up visit within 90&#xD;
        (±7) days after the last dose. If the subjects who achieve complete response (CR), partial&#xD;
        response (PR), or stable disease (SD) with clinical benefit discontinue the investigational&#xD;
        product, the follow-up visits will be completed every 12 weeks until disease progression,&#xD;
        informed consent withdrawn by subject, death, or loss to follow-up, or end of study&#xD;
        (whichever occurs first). Survival follow-up will be performed for a maximum of 2 years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 4, 2023</start_date>
    <completion_date type="Anticipated">January 23, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 26, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>DLTs</measure>
      <time_frame>Baseline up to 28 days after the first dose</time_frame>
      <description>Dose Limiting Toxicities</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MTD(maximum tolerated dose)</measure>
      <time_frame>From start of treatment to treatment termination visit, up to 48 weeks</time_frame>
      <description>To determine the maximum tolerated dose (MTD) of IMM47 in subjects with advanced solid tumors</description>
    </primary_outcome>
    <primary_outcome>
      <measure>adverse events (AEs)</measure>
      <time_frame>Baseline up to 30 days after the last dose of study drug, up to 48 weeks</time_frame>
      <description>Incidence and characteristics of adverse events (AEs)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>RP2D (recommended Phase 2 dose)</measure>
      <time_frame>From start of treatment to treatment termination visit, up to 48 weeks</time_frame>
      <description>To determine the recommended Phase 2 dose (RP2D) of IMM47 in in subjects with advanced solid tumors</description>
    </primary_outcome>
    <primary_outcome>
      <measure>serious adverse events (SAEs)</measure>
      <time_frame>Baseline up to 30 days after the last dose of study drug, up to 48 weeks</time_frame>
      <description>Incidence and characteristics of serious adverse events (SAEs)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum Plasma Concentration (Cmax)</measure>
      <time_frame>48 weeks of treatment cycles</time_frame>
      <description>Maximum Plasma Concentration observed in patients with IMM47 dosed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to maximum concentration (Tmax)</measure>
      <time_frame>48 weeks of treatment cycles</time_frame>
      <description>time to maximum concentration observed in patients with IMM47 dosed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination half-life (t1/2)</measure>
      <time_frame>48 weeks of treatment cycles</time_frame>
      <description>elimination half-life (t1/2) observed in patients with IMM47 dosed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunogenicity</measure>
      <time_frame>48 weeks of treatment cycles</time_frame>
      <description>Positive rates of anti-drug antibodies (ADA)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Rate Response (ORR)</measure>
      <time_frame>When the last subject enrolled completes approximately 48 weeks of treatment</time_frame>
      <description>ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>When the last subject enrolled completes approximately 48 weeks of treatment</time_frame>
      <description>defined as the percentage of subjects with tumors who have complete response (CR), partial response (PR), and stable disease (SD)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DoR)</measure>
      <time_frame>When the last subject enrolled completes approximately 48 weeks of treatment</time_frame>
      <description>defined as the time from the first record of objective response to the first tumor progression or death of any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free Survival (PFS)</measure>
      <time_frame>When the last subject enrolled completes approximately 48 weeks of treatment</time_frame>
      <description>defined as the time from the start of treatment to tumor progression or death of any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC(0-tlast)</measure>
      <time_frame>48 weeks of treatment cycles</time_frame>
      <description>area under the serum concentration-time curve from time 0 to the time of last quantifiable concentration (AUC0-tlast) in patients with IMM47 dosed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC0-inf</measure>
      <time_frame>48 weeks of treatment cycles</time_frame>
      <description>area under the serum concentration-time curve from 0 to time infinity (AUC0-inf) in patients with IMM47 dosed</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Oncology</condition>
    <arm_group>
      <arm_group_label>Dose escalation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>It's a dose escalation to identify the Maximum Tolerated dose (MTD) , recommended Phase II dose (RP2D) of IMM47, an accelerated titration method and the traditional &quot;3+3&quot; design method will be adopted. IMM47 will be sequentially escalated at the dose of 5 μg/kg，50 μg/kg, 250 μg/kg，1.0 mg/kg，3.0 mg/kg and 5.0 mg/kg or higher dose levels, administered via intravenous infusion every 2 weeks in 28-day treatment cycles.&#xD;
  The duration of the infusion is 120 min (± 10 min) for the 1st infusion and 60 min (± 5 min) for subsequent infusions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>IMM47</intervention_name>
      <description>IMM47 is humanized mAb targeting CD24 to be administered via intravenous infusion every 2 weeks in 28-day treatment cycles.</description>
      <arm_group_label>Dose escalation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 18 years at the time of signing the ICF.&#xD;
  &#xD;
            2. With an expected life expectancy of ≥ 12 weeks.&#xD;
  &#xD;
            3. With an ECOG performance status score of 0-1.&#xD;
  &#xD;
            4. For phase Ia, subjects diagnosed histologically or cytologically with advanced&#xD;
               solidtumors (preferred but not limited to ovarian, esophageal, breast, lung,&#xD;
               colorectal, hepatocellular, pancreatic, urothelial, prostate, and head and neck&#xD;
               cancers) that have failed previous standard treatments or no standard treatment is&#xD;
               available.&#xD;
  &#xD;
            5. The intervals for discontinuing the last anti-tumor therapy prior to the first dose of&#xD;
               the investigational product are required as follows Subjects who previously received&#xD;
               chemotherapeutic agents must have discontinued the drug for more than 3 weeks.&#xD;
  &#xD;
               Subjects who previously received small-molecule targeted therapy must have&#xD;
               discontinued treatment for more than 2 weeks or 5 half-lives of the drug (whichever is&#xD;
               longer).&#xD;
  &#xD;
               Subjects who previously received monoclonal antibodies (eg. CD20 antibody, PD-1/PD-L1&#xD;
               antibody) must have discontinued the treatment for more than 4 weeks.&#xD;
  &#xD;
               Subjects who previously underwent palliative radiation therapy must have discontinued&#xD;
               the treatment for more than 4 weeks.&#xD;
  &#xD;
            6. With suitable organ and hematopoietic functions:&#xD;
  &#xD;
               Neutrophil count ≥1.5 × 109/L. (no growth factor therapy within 4 weeks prior to&#xD;
               Screening).&#xD;
  &#xD;
               Platelet count ≥100 × 109/L ; for subjects with HCC, platelet count ≥75 ×109 /L&#xD;
               Hemoglobin ≥ 90 g/L (subjects may be transfused &gt;2 weeks before screening, but should&#xD;
               not be transfusion-dependent).&#xD;
  &#xD;
               Total Bilirubin (TBIL) ≤ 1.5 × ULN (or ≤ 3.0 × ULN if subject has a documented history&#xD;
               of Gilbert's syndrome or liver metastases).&#xD;
  &#xD;
               Both aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN (or both&#xD;
               AST and ALT ≤ 5.0 × ULN if subject has a documented history of liver metastases).&#xD;
  &#xD;
               International normalized ratio (INR) ≤1.5 × ULN, or activated partial thromboplastin&#xD;
               time (APTT) ≤ 1.5× ULN.&#xD;
  &#xD;
               Left ventricular ejection fraction (LVEF) ≥ 50%. Serum creatinine ≤1.5 × ULN or&#xD;
               creatinine clearance (CrCl) ≥ 40 mL/min (Cockcroft and Gault Equation) if serum&#xD;
               creatinine &gt;1.5 ULN. Lower calculated creatinine clearance values may be allowed at&#xD;
               the Investigator's discretion and in consultation with the Medical Monitor and Sponsor&#xD;
  &#xD;
            7. Adverse events associated with previous anti-tumor therapies should have recovered to&#xD;
               ≤ Grade 1 (CTCAE version 5.0) (except for toxicities not considered a safety risk such&#xD;
               as alopecia, skin pigmentation, and other non-clinically significant abnormalities).&#xD;
  &#xD;
            8. Female subjects (based on sex assigned at birth) of childbearing potential must be&#xD;
               tested negative for serum pregnancy test during the screening period before receiving&#xD;
               the first administration of IMM47; any female subject of childbearing potential must&#xD;
               agree to take effective contraceptive measures during the entire study and within 6&#xD;
               months after last dose of the investigational product. A subject is considered to have&#xD;
               childbearing potential if he/she is biologically capable of having children and has a&#xD;
               heterosexual sex life. Female subjects meeting at least one of the following criteria&#xD;
               are deemed to be without childbearing potential:&#xD;
  &#xD;
               Has undergone hysterectomy or bilateral oophorectomy Medically confirmed with ovarian&#xD;
               failure Medically confirmed as postmenopausal (menstruation has stopped for 12&#xD;
               consecutive months not for pathological or physiological reasons)&#xD;
  &#xD;
               Acceptable forms of contraception for female subjects are:&#xD;
  &#xD;
               Should not have sexual intercourse or genital contact with a male partner, or use a&#xD;
               method of birth control for the duration of the study participation and for 6 months&#xD;
               last dose of the investigational product.&#xD;
  &#xD;
               Must agree to use one form of contraception, including sterilization, combined&#xD;
               estrogen and progestogen containing hormonal contraception pills or an intravaginal,&#xD;
               transdermal, or intrauterine device.&#xD;
  &#xD;
               Intrauterine hormone-releasing system. Bilateral tubal occlusion (surgical procedure&#xD;
               that involves blocking by cutting, burning or removing sections, or placing clips of&#xD;
               the fallopian tubes to prevent the ovum [egg] from being fertilized).&#xD;
  &#xD;
               A vasectomized partner (surgical procedure that involves cutting and sealing the tubes&#xD;
               used to transport semen from the testicles to the penis, thereby rendering&#xD;
               infertility).&#xD;
  &#xD;
               Male subjects with female partners of childbearing potential are eligible to&#xD;
               participate if they agree to ONE of the following for the duration of the study and&#xD;
               until 90 days after the last dose of the study treatment:&#xD;
  &#xD;
               Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle&#xD;
               (abstinent on a long-term and persistent basis) and agree to remain abstinent.&#xD;
  &#xD;
               Agree to use a male condom and have their partner use a contraceptive method with a&#xD;
               failure rate of &lt;1% per year as described below when having penile-vaginal intercourse&#xD;
               with a WOCBP who is not currently pregnant.&#xD;
  &#xD;
               In addition, male subjects must refrain from donating sperm for the duration of the&#xD;
               study and for 90 days after the last dose of study treatment.&#xD;
  &#xD;
               Male subjects with a pregnant or breastfeeding partner must agree to remain abstinent&#xD;
               from penile-vaginal intercourse or use a male condom during each episode of penile&#xD;
               penetration for the duration of the study and until 90 days after the last dose of the&#xD;
               study treatment.&#xD;
  &#xD;
            9. Subjects who voluntarily sign the informed consent form, understand the study, and are&#xD;
               willing to comply with the protocol, and are able to complete all trial procedures.&#xD;
  &#xD;
           10. At least one measurable or evaluable tumor lesion. For solid tumor: Measurable lesion&#xD;
               according to RECIST version 1.1 is defined as tumor lesions ≥10 mm in longest diameter&#xD;
               or pathologic node ≥ 15 mm in short axis.&#xD;
  &#xD;
           11. For both phase Ia and Ib, subjects must agree to provide archived tumor tissue samples&#xD;
               for CD24 IHC expression assessment by the central laboratory. In the setting where&#xD;
               archival material is unavailable or unsuitable for use (e.g., recently diagnosed&#xD;
               subjects or diagnosed with fine needle aspiration), the subject must consent and&#xD;
               undergo fresh tumor biopsy (biopsy at acceptable risk as judged by the Investigator).&#xD;
               The requirement for fresh biopsy collected from a given subject could be waived after&#xD;
               the discussion with the Sponsor, if the tumor tissues are not safely accessible as&#xD;
               determined by the Investigator, or the tumor biopsies have to be obtained from sites&#xD;
               that require significant risk procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects who previously received CD24 targeted therapy.&#xD;
  &#xD;
            2. Prior allogeneic hematopoietic stem cell transplant or other organ transplants.&#xD;
  &#xD;
            3. Subjects with active central nervous system (CNS) metastases and primary CNS Lymphoma&#xD;
               (Subjects with stable treated CNS lesions who are off corticosteroid therapy for at&#xD;
               least 3 weeks are not considered active).&#xD;
  &#xD;
            4. Subjects in need of immediate cytoreduction therapy.&#xD;
  &#xD;
            5. Significant medical disease or conditions, as assessed by the Investigators and&#xD;
               Sponsor that would substantially increase the risk-benefit ratio of participating in&#xD;
               the study. This includes but is not limited to:&#xD;
  &#xD;
               Uncontrolled hypertension (systolic BP &gt; 160 mmHg or diastolic BP &gt; 90 mmHg),&#xD;
               pulmonary hypertension, or unstable angina.&#xD;
  &#xD;
               New York Heart Association (NYHA) Grade II or higher congestive heart failure. History&#xD;
               of myocardial infarction, or bypass surgery or stent placement within 6 months prior&#xD;
               to the first dose of the investigational product.&#xD;
  &#xD;
               Severe arrhythmia requiring treatment (except for atrial fibrillation or paroxysmal&#xD;
               supraventricular tachycardia that, according to the judgment of the investigators, do&#xD;
               not affect the study).&#xD;
  &#xD;
               QTc interval &gt; 450 ms for males and &gt; 470 ms for females (Fridericia's Formula).&#xD;
  &#xD;
               History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6&#xD;
               months prior to the first dose of investigational product.&#xD;
  &#xD;
               Concurrent interstitial lung disease (ILD) (except for radiation therapy-induced loco&#xD;
               regional interstitial pneumonia), severe chronic obstructive pulmonary disease, severe&#xD;
               pulmonary insufficiency.&#xD;
  &#xD;
               Diseases that may cause gastrointestinal bleeding or perforation. Known inherited or&#xD;
               acquired bleeding disorders Uncontrolled diabetes mellitus. Thoracoabdominal or&#xD;
               pericardial effusions that cannot be controlled by puncture and drainage and require&#xD;
               repeated drainage or with significant symptoms.&#xD;
  &#xD;
               History of liver disease, including cirrhosis, alcoholic liver disease, etc.&#xD;
  &#xD;
            6. Concurrent medical condition requiring systemic corticosteroids (prednisone daily dose&#xD;
               &gt; 10 mg or equivalent dose) within 7 days prior to first dose of the investigational&#xD;
               product or during the study, or other immunosuppressive medications, but not including&#xD;
               locoregional corticoids by intranasal, inhalated or other routes of administration, or&#xD;
               physiological-dose corticoids systemic-therapy.&#xD;
  &#xD;
            7. Known active infection including hepatitis B (known positive HBV surface antigen&#xD;
               (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2&#xD;
               antibodies).&#xD;
  &#xD;
               Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B&#xD;
               core antibody [anti-HBc] and absence of HBsAg) are eligible.&#xD;
  &#xD;
               Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain&#xD;
               reaction is negative for HCV RNA.&#xD;
  &#xD;
               Subjects with HIV infection, and CD4+ T-cell (CD4+) counts &lt; 350 cells/μL; or with&#xD;
               acquired immunodeficiency syndrome (AIDS) - defining opportunistic infections within&#xD;
               the past 12 months; or with uncontrolled opportunistic infections; or have an HIV&#xD;
               viral load &gt;400 copies/mL.&#xD;
  &#xD;
            8. Subjects with uncontrollable severe active infections (such as septicemia, bacteremia,&#xD;
               or viremia).&#xD;
  &#xD;
            9. Subjects who received live attenuated vaccine within 4 weeks prior to the first dose&#xD;
               of the investigational product, or plan to receive attenuated vaccine during the&#xD;
               study.&#xD;
  &#xD;
           10. Subjects who underwent a major surgery within 4 weeks prior to the first dose or plan&#xD;
               to undergo a major surgery in 3 months after receiving the investigational drug&#xD;
               (excluding catheterization, peripherally inserted central catheter, etc.).&#xD;
  &#xD;
           11. Females who have a positive serum pregnancy test or who are lactating or planning to&#xD;
               become pregnant during the study or within 6 months after the last dose of&#xD;
               investigational product.&#xD;
  &#xD;
           12. Received investigational therapy or used an investigational device within 4 weeks&#xD;
               prior to the first dose of study treatment&#xD;
  &#xD;
           13. History of psychiatric illness or substance abuse likely to interfere with the ability&#xD;
               to comply with protocol requirements or giving informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jim Coward, A/Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>Icon Cancer Centre South Brisbane, QLD</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Charlotte Lemech, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Scientia Clinical Research Ltd, NSW</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Megan Crumbaker, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Macquarie University Clinical Trials Unit (MQ CTU)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>David Martin, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>John Flynn Private Hospital, QLD</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Qiying Lu, Dr.</last_name>
      <phone>+86 21 38016387</phone>
      <email>qiying.lu@immuneonco.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bin Pan, Dr</last_name>
      <phone>+86 21 38016387</phone>
      <email>bin.pan@immuneonco.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Scientia Clinical Research Ltd, NSW</name>
        <address>
          <city>Sydney</city>
          <state>New South Wales</state>
          <zip>2031</zip>
          <country>Australia</country>
        </address>
      </facility>
      <contact>
        <last_name>Charlotte Lemech, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Macquarie University Clinical Trials Unit (MQ CTU)</name>
        <address>
          <city>Syd</city>
          <state>New South Wales</state>
          <zip>2109</zip>
          <country>Australia</country>
        </address>
      </facility>
      <contact>
        <last_name>Megan Crumbaker, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Icon Cancer Centre South Brisbane, QLD</name>
        <address>
          <city>Brisbane</city>
          <state>Queensland</state>
          <zip>4101</zip>
          <country>Australia</country>
        </address>
      </facility>
      <contact>
        <last_name>Jim Coward, A Prof</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>John Flynn Private Hospital</name>
        <address>
          <city>Gold Coast</city>
          <state>Queensland</state>
          <zip>4224</zip>
          <country>Australia</country>
        </address>
      </facility>
      <contact>
        <last_name>David Martin, Dr</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ADVANCED SOLID TUMORS</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>all IPD that underlie results in a publication</ipd_description>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>starting in Jun 1st 2025.</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05985083
  org study id: IMM47-201
  nct id: NCT05985083
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This is a first-in-human (FIH), open-label, multi-center, phase I study to evaluate the
        safety, tolerance, pharmacokinetics (PK), immunogenicity, preliminary anti-tumor activity,
        pharmacodynamics, and biomarker activity of IMM47 monotherapy in subjects with advanced solid
        tumors.
  In phase Ia phase, approximately 17-48 eligible subjects with advanced solid tumors will be
        enrolled, and an accelerated titration method and the traditional "3+3" design method will be
        adopted to explore the safety, tolerability, PK, immunogenicity, and anti-tumor activity of 6
        dose levels of IMM47: 5 μg/kg, 50 μg/kg, 250 μg/kg, 1.0 mg/kg, 3.0 mg/kg and 5.0 mg/kg or
        higher, to determine the MTD and RP2D.
  
        Accelerated dose cohorts: At the dose cohorts of 5 μg/kg and 50 μg/kg, one subject will be
        enrolled at first, and the conventional "3+3" design will be altered and the additional 2 or
        5 subjects would be enrolled if any ≥ Grade 2 drug related toxicities are observed during the
        first 28-day cycle (DLT observational period).
  
        "3+3" dose cohorts: Thereafter, at least three subjects will be enrolled in each dose cohort
        at the 250 μg/kg, 1.0 mg/kg, 3.0 mg/kg and 5.0 mg/kg dose levels sequentially. There will be
        a minimum interval of 48 hours between the 1st and 2nd subjects being dosed in each "3+3"
        dose cohort. If no DLTs occur in a dose cohort of 3 subjects during the first cycle (DLT
        observational period), 3 subjects will be enrolled at the next higher dose level. If 1 of 3
        subjects in a cohort experiences a DLT, an additional 3 subjects will be enrolled at that
        dose level. If only 1 of 6 subjects experiences a DLT, then 3 subjects will be enrolled at
        the next higher dose level. If 2 or more subjects experienced DLTs within a cohort, dose
        escalation will be halted and 3 more subjects will be enrolled at the previous lower
        (tolerated) dose level until that cohort has 6 evaluable subjects. Depending on toxicity, the
        dose deescalation to an intermediate dose may occur. Higher doses than 5.0 mg/kg may be
        explored under the decision of Safety Review Committee (SRC). A total of 6 subjects must be
        enrolled at the MTD (or the highest dose studied where no more than 1 of 6 subjects
        experiences a DLT if the MTD is not identified) and evaluated at the end of Cycle 1 before
        any subject is dosed in the expansion cohorts.
  
        Continued dosing with IMM47 beyond the second cycle will be offered to subjects who do not
        experience disease progression or significant toxicity. Subjects who are benefiting from
        IMM47 will receive the treatment up to 12 cycles, at investigator's discretion. Subjects
        discontinuing the study treatment early for any reason will complete an end-of-treatment
        (EOT) visit within 30 (+7) days after the last dose, and a safety follow-up visit within 90
        (±7) days after the last dose. If the subjects who achieve complete response (CR), partial
        response (PR), or stable disease (SD) with clinical benefit discontinue the investigational
        product, the follow-up visits will be completed every 12 weeks until disease progression,
        informed consent withdrawn by subject, death, or loss to follow-up, or end of study
        (whichever occurs first). Survival follow-up will be performed for a maximum of 2 years.
  allocation: N/A
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: DLTs
  time frame: Baseline up to 28 days after the first dose
  description: Dose Limiting Toxicities
  measure: MTD(maximum tolerated dose)
  time frame: From start of treatment to treatment termination visit, up to 48 weeks
  description: To determine the maximum tolerated dose (MTD) of IMM47 in subjects with advanced solid tumors
  measure: adverse events (AEs)
  time frame: Baseline up to 30 days after the last dose of study drug, up to 48 weeks
  description: Incidence and characteristics of adverse events (AEs)
  measure: RP2D (recommended Phase 2 dose)
  time frame: From start of treatment to treatment termination visit, up to 48 weeks
  description: To determine the recommended Phase 2 dose (RP2D) of IMM47 in in subjects with advanced solid tumors
  measure: serious adverse events (SAEs)
  time frame: Baseline up to 30 days after the last dose of study drug, up to 48 weeks
  description: Incidence and characteristics of serious adverse events (SAEs)
  measure: Maximum Plasma Concentration (Cmax)
  time frame: 48 weeks of treatment cycles
  description: Maximum Plasma Concentration observed in patients with IMM47 dosed
  measure: Time to maximum concentration (Tmax)
  time frame: 48 weeks of treatment cycles
  description: time to maximum concentration observed in patients with IMM47 dosed
  measure: Elimination half-life (t1/2)
  time frame: 48 weeks of treatment cycles
  description: elimination half-life (t1/2) observed in patients with IMM47 dosed
  measure: Immunogenicity
  time frame: 48 weeks of treatment cycles
  description: Positive rates of anti-drug antibodies (ADA)
  measure: Overall Rate Response (ORR)
  time frame: When the last subject enrolled completes approximately 48 weeks of treatment
  description: ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)
  measure: Disease control rate (DCR)
  time frame: When the last subject enrolled completes approximately 48 weeks of treatment
  description: defined as the percentage of subjects with tumors who have complete response (CR), partial response (PR), and stable disease (SD)
  measure: Duration of response (DoR)
  time frame: When the last subject enrolled completes approximately 48 weeks of treatment
  description: defined as the time from the first record of objective response to the first tumor progression or death of any cause
  measure: Progression-free Survival (PFS)
  time frame: When the last subject enrolled completes approximately 48 weeks of treatment
  description: defined as the time from the start of treatment to tumor progression or death of any cause
  measure: AUC(0-tlast)
  time frame: 48 weeks of treatment cycles
  description: area under the serum concentration-time curve from time 0 to the time of last quantifiable concentration (AUC0-tlast) in patients with IMM47 dosed
  measure: AUC0-inf
  time frame: 48 weeks of treatment cycles
  description: area under the serum concentration-time curve from 0 to time infinity (AUC0-inf) in patients with IMM47 dosed
  arm group label: Dose escalation
  arm group type: Experimental
  description: It's a dose escalation to identify the Maximum Tolerated dose (MTD) , recommended Phase II dose (RP2D) of IMM47, an accelerated titration method and the traditional "3+3" design method will be adopted. IMM47 will be sequentially escalated at the dose of 5 μg/kg，50 μg/kg, 250 μg/kg，1.0 mg/kg，3.0 mg/kg and 5.0 mg/kg or higher dose levels, administered via intravenous infusion every 2 weeks in 28-day treatment cycles.
  The duration of the infusion is 120 min (± 10 min) for the 1st infusion and 60 min (± 5 min) for subsequent infusions.
  intervention type: Drug
  intervention name: IMM47
  description: IMM47 is humanized mAb targeting CD24 to be administered via intravenous infusion every 2 weeks in 28-day treatment cycles.
  arm group label: Dose escalation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jim Coward, A/Prof
  role: Principal Investigator
  affiliation: Icon Cancer Centre South Brisbane, QLD
  last name: Charlotte Lemech, Dr
  role: Principal Investigator
  affiliation: Scientia Clinical Research Ltd, NSW
  last name: Megan Crumbaker, Dr
  role: Principal Investigator
  affiliation: Macquarie University Clinical Trials Unit (MQ CTU)
  last name: David Martin, Dr
  role: Principal Investigator
  affiliation: John Flynn Private Hospital, QLD
  last name: Qiying Lu, Dr.
  phone: +86 21 38016387
  email: qiying.lu@immuneonco.com
  last name: Bin Pan, Dr
  phone: +86 21 38016387
  email: bin.pan@immuneonco.com
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: Australia
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: Yes
  ipd description: all IPD that underlie results in a publication
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: starting in Jun 1st 2025.