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/NCT05982080</url>
    </required_header>
    <id_info>
      <org_study_id>FP002-CT1001-CN</org_study_id>
      <nct_id>NCT05982080</nct_id>
    </id_info>
    <brief_title>A Study to Investigate FP002 in Subjects With Advanced Malignancies</brief_title>
    <official_title>A Phase 1 Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics Activity of FP002 in Subjects With Advanced Malignancies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guangdong Fapon Biopharma Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Guangdong Fapon Biopharma Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this phase 1 study is to assess the safety, and tolerability of FP002 to&#xD;
        determine the dose recommended for dose expansion in subjects with advanced solid tumor.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a phase 1 study of FP002 as monotherapy in patients with advanced solid tumor.&#xD;
        The study will evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile,&#xD;
        immunogenicity, and preliminary anti-tumor activity of FP002 in patients with advanced solid&#xD;
        tumors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">July 2026</completion_date>
    <primary_completion_date type="Anticipated">April 2025</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>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Severity (as graded by CTCAE v5.0) of Dose Limiting Toxicity (DLT)</measure>
      <time_frame>During the first 4 week treatment cycle</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Severity (as graded by CTCAE v5.0) of treatment-emergent AEs (TEAEs)</measure>
      <time_frame>up to 24 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Severity (as graded by CTCAE v5.0) of serious adverse events (SAEs)</measure>
      <time_frame>up to 24 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Severity (as graded by CTCAE v5.0) of adverse events of special interest (AESIs)</measure>
      <time_frame>up to 24 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Severity (as graded by CTCAE v5.0) of adverse events assessed</measure>
      <time_frame>up to 24 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum plasma concentration (Cmax) of FP002</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the curve from time zero to the last measurable time point (AUC0-t) of FP002</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the curve extrapolated to infinity (AUC0-inf)of FP002</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to reach maximum plasma concentration (Tmax) of FP002</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal elimination half-life (t1/2) of FP002</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent volume of distribution (Vd) of FP002</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clearance rate (CLz)</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal elimination rate constant (λz)</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean retention time (MRT)</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum plasma concentration during the dosing interval at steady state (Cmax,ss)</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimum plasma concentration during the dosing interval at steady state (Cmin,ss)</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average steady state concentration (Cav)</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Steady-state clearance rate (CLss)</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Steady-state volume of distribution (Vss)</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Accumulation index (Rac)</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Degree of fluctuation (DF)</measure>
      <time_frame>up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DoR) based on RECIST V1.1</measure>
      <time_frame>Up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR) based on RECIST V1.1</measure>
      <time_frame>Up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall response rate (ORR) based on RECIST V1.1</measure>
      <time_frame>Up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival (PFS) based on RECIST V1.1</measure>
      <time_frame>Up to 24 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-drug antibody</measure>
      <time_frame>Up to 24 months</time_frame>
      <description>Incidence, onset time and titer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neutralizing antibody</measure>
      <time_frame>Up to 24 months</time_frame>
      <description>Incidence, onset time and titer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Receptor of occupancy in RBC/CD3+ T cell</measure>
      <time_frame>Up to 24 months</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">27</enrollment>
    <condition>Advanced Solid Tumor</condition>
    <arm_group>
      <arm_group_label>FP002 Injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dose escalation: FP002</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>FP002 Injection</intervention_name>
      <description>Up to 6 FP002 dose levels (0.3, 1.0, 3.0, 10, 20, 30 mg/kg administered intravenously may be evaluated. Subjects will receive weekly infusions of FP002 until disease progression, unacceptable toxicity, consent withdrawal, physician decision, or start of subsequent anticancer therapy, whichever occurs first.</description>
      <arm_group_label>FP002 Injection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signed informed consent form (ICF) and was able to comply with the protocol.&#xD;
  &#xD;
            2. Male or female subjects ≥ 18 years of age on the day of ICF signing.&#xD;
  &#xD;
            3. A life expectancy of &gt; 3 months.&#xD;
  &#xD;
            4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.&#xD;
  &#xD;
            5. Adequate organ and bone marrow function confirmed at screening and within 7 days&#xD;
               before the first dose of study treatment.&#xD;
  &#xD;
            6. Subjects with histologically or cytological confirmed malignancy diagnosis.&#xD;
  &#xD;
            7. Documented advanced solid tumors, defined as patients have no standard treatment or&#xD;
               who have failed/are intolerant to standard treatment according to the investigator's&#xD;
               judgment.&#xD;
  &#xD;
            8. Documented with at least 1 measurable lesion as assessed by RECIST 1.1.&#xD;
  &#xD;
            9. Toxicity from prior anti-tumor treatment has resolved to ≤ Grade 1 as defined by NCI&#xD;
               CTCAE v5.0.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects who have received other anti-CD47 or anti- SIRPα agents.&#xD;
  &#xD;
            2. Prior organ or tissue allograft except for hematopoietic stem cell transplantation.&#xD;
  &#xD;
            3. Treatment with investigational therapy within 4 weeks prior to initiation of study&#xD;
               drug.&#xD;
  &#xD;
            4. Severe infection requiring hospitalization or IV antibiotics, antivirals or&#xD;
               antifungals within 14 days prior to enrollment.&#xD;
  &#xD;
            5. Subjects who have received chemotherapy within 4 weeks or 5 half-lives (whichever is&#xD;
               shorter) before the first dose (within 6 weeks before the first dose of mitomycin or&#xD;
               nitrosoureas) or received immunotherapy, radical radiotherapy or major surgery within&#xD;
               4 weeks or palliative radiotherapy within 2 weeks.&#xD;
  &#xD;
            6. Subjects who have experienced active autoimmune disease requiring systemic therapy&#xD;
               within the past 2 years.&#xD;
  &#xD;
            7. A positive test result for severe acute respiratory syndrome coronavirus 2&#xD;
               (SARS-CoV-2) by a certified nucleic acid test within the last 30 days before the first&#xD;
               dose of study treatment.&#xD;
  &#xD;
            8. Cardiovascular dysfunction or clinically significant cardiac disease.&#xD;
  &#xD;
            9. Active infection with hepatitis C.&#xD;
  &#xD;
           10. Receipt of a live vaccine within 30 days prior to the first dose of study treatment.&#xD;
  &#xD;
           11. Known hypersensitivity to either the drug substances or inactive ingredient of FP002.&#xD;
  &#xD;
           12. Known human immunodeficiency virus (HIV) positive.&#xD;
  &#xD;
           13. A history of other malignancies other than effectively treated basal cell carcinoma of&#xD;
               skin, squamous cell carcinoma of skin, or effectively resected carcinoma in situ of&#xD;
               the cervix.&#xD;
  &#xD;
           14. Known inherited or acquired bleeding disorders.&#xD;
  &#xD;
           15. Any other medical, family, social or mental conditions that the investigator considers&#xD;
               unsuitable for participation in the study.&#xD;
  &#xD;
           16. Daily requirement for corticosteroids (≥10 mg/kg) within 2 weeks prior to Day 1 of&#xD;
               Cycle 1.&#xD;
  &#xD;
           17. Women who are lactating or pregnant as confirmed by pregnancy test within 7 days&#xD;
               before the first dose of study treatment. Unwilling to use adequate contraceptive&#xD;
               methods during the study and for at least 7 months after the last dose of study&#xD;
               treatment.&#xD;
  &#xD;
           18. Presence of active brain metastases&#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>Yuping Sun, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shangdong Cancer Hospital &amp; Institute</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Linlin Wang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shangdong Cancer Hospital &amp; Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Arron Wang</last_name>
      <phone>+86 13926091581</phone>
      <email>clinitrial.register@fapon.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Vincent Huo</last_name>
      <phone>+86 13825280524</phone>
      <email>clinitrial.register@fapon.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Xiamen University</name>
        <address>
          <city>Xiamen</city>
          <state>Fujian</state>
          <zip>361003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Wang Sheng</last_name>
        <email>shengwang81@126.com</email>
      </contact>
      <investigator>
        <last_name>Wang Sheng, M.M.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Shangdong Cancer Hospital &amp; Institute</name>
        <address>
          <city>Jinan</city>
          <state>Shangdong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yuping Sun, MD</last_name>
        <phone>+86-531-67627156</phone>
        <email>13370582181@163.com</email>
      </contact>
      <investigator>
        <last_name>Yuping Kong, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Linlin Wang, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Linyi Cancer Hospital</name>
        <address>
          <city>Linyi</city>
          <state>Shangdong</state>
          <zip>276000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Zhen Wang</last_name>
        <email>LYSZLYYNSK@163.com</email>
      </contact>
      <investigator>
        <last_name>Zhen Wang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05982080
  org study id: FP002-CT1001-CN
  nct id: NCT05982080
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this phase 1 study is to assess the safety, and tolerability of FP002 to
        determine the dose recommended for dose expansion in subjects with advanced solid tumor.
  This study is a phase 1 study of FP002 as monotherapy in patients with advanced solid tumor.
        The study will evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile,
        immunogenicity, and preliminary anti-tumor activity of FP002 in patients with advanced solid
        tumors.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Severity (as graded by CTCAE v5.0) of Dose Limiting Toxicity (DLT)
  time frame: During the first 4 week treatment cycle
  measure: Severity (as graded by CTCAE v5.0) of treatment-emergent AEs (TEAEs)
  time frame: up to 24 months
  measure: Severity (as graded by CTCAE v5.0) of serious adverse events (SAEs)
  time frame: up to 24 months
  measure: Severity (as graded by CTCAE v5.0) of adverse events of special interest (AESIs)
  time frame: up to 24 months
  measure: Severity (as graded by CTCAE v5.0) of adverse events assessed
  time frame: up to 24 months
  measure: Maximum plasma concentration (Cmax) of FP002
  time frame: up to 24 months
  measure: Area under the curve from time zero to the last measurable time point (AUC0-t) of FP002
  time frame: up to 24 months
  measure: Area under the curve extrapolated to infinity (AUC0-inf)of FP002
  time frame: up to 24 months
  measure: Time to reach maximum plasma concentration (Tmax) of FP002
  time frame: up to 24 months
  measure: Terminal elimination half-life (t1/2) of FP002
  time frame: up to 24 months
  measure: Apparent volume of distribution (Vd) of FP002
  time frame: up to 24 months
  measure: Clearance rate (CLz)
  time frame: up to 24 months
  measure: Terminal elimination rate constant (λz)
  time frame: up to 24 months
  measure: Mean retention time (MRT)
  time frame: up to 24 months
  measure: Maximum plasma concentration during the dosing interval at steady state (Cmax,ss)
  time frame: up to 24 months
  measure: Minimum plasma concentration during the dosing interval at steady state (Cmin,ss)
  time frame: up to 24 months
  measure: Average steady state concentration (Cav)
  time frame: up to 24 months
  measure: Steady-state clearance rate (CLss)
  time frame: up to 24 months
  measure: Steady-state volume of distribution (Vss)
  time frame: up to 24 months
  measure: Accumulation index (Rac)
  time frame: up to 24 months
  measure: Degree of fluctuation (DF)
  time frame: up to 24 months
  measure: Duration of response (DoR) based on RECIST V1.1
  time frame: Up to 24 months
  measure: Disease control rate (DCR) based on RECIST V1.1
  time frame: Up to 24 months
  measure: Overall response rate (ORR) based on RECIST V1.1
  time frame: Up to 24 months
  measure: Progression free survival (PFS) based on RECIST V1.1
  time frame: Up to 24 months
  measure: Anti-drug antibody
  time frame: Up to 24 months
  description: Incidence, onset time and titer
  measure: Neutralizing antibody
  time frame: Up to 24 months
  description: Incidence, onset time and titer
  measure: Receptor of occupancy in RBC/CD3+ T cell
  time frame: Up to 24 months
  arm group label: FP002 Injection
  arm group type: Experimental
  description: Dose escalation: FP002
  intervention type: Drug
  intervention name: FP002 Injection
  description: Up to 6 FP002 dose levels (0.3, 1.0, 3.0, 10, 20, 30 mg/kg administered intravenously may be evaluated. Subjects will receive weekly infusions of FP002 until disease progression, unacceptable toxicity, consent withdrawal, physician decision, or start of subsequent anticancer therapy, whichever occurs first.
  arm group label: FP002 Injection
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yuping Sun, MD
  role: Principal Investigator
  affiliation: Shangdong Cancer Hospital & Institute
  last name: Linlin Wang, MD
  role: Principal Investigator
  affiliation: Shangdong Cancer Hospital & Institute
  last name: Arron Wang
  phone: +86 13926091581
  email: clinitrial.register@fapon.com
  last name: Vincent Huo
  phone: +86 13825280524
  email: clinitrial.register@fapon.com
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: No