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/NCT05983432</url>
    </required_header>
    <id_info>
      <org_study_id>BL-B01D1-LUNG-101</org_study_id>
      <nct_id>NCT05983432</nct_id>
    </id_info>
    <brief_title>Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC)</brief_title>
    <official_title>A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>SystImmune Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>SystImmune Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1&#xD;
        in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        BL-B01D1-LUNG-101 is a global, multi-center, Phase 1 study to evaluate the safety,&#xD;
        tolerability, pharmacokinetics , and initial efficacy of BL-B01D1 in participants with&#xD;
        metastatic or unresectable NSCLC.&#xD;
  &#xD;
        This study will be conducted in two different dosing schedules (Cohort A and Cohort B) and&#xD;
        three parts (dose escalation, dose finding and dose expansion). Cohort A will be dosed on Day&#xD;
        1 and Day 8 of a continuous 21-day treatment cycle. Cohort B will be dosed on Day 1 of a&#xD;
        continuous 21-day treatment cycle. Each Cohort has different dose groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Participants with Dose-limiting toxicities</measure>
      <time_frame>One year</time_frame>
      <description>Measuring the number of patients Dose-limiting toxicities (DLTs). A DLT is defined as any of the following events that are not clearly due to the underlying disease or extraneous causes:&#xD;
  Hematological toxicities:&#xD;
  Grade 4 neutrophil count decreased lasting &gt;7 days&#xD;
  Grade ≥3 febrile neutropenia&#xD;
  Grade ≥3 platelet count decreased with clinically significant hemorrhage.&#xD;
  Non-Hematological toxicities:&#xD;
  Death&#xD;
  Hy's law cases&#xD;
  Grade ≥3 non-hematological toxicities,</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs),</measure>
      <time_frame>One year</time_frame>
      <description>Measuring the number of patients with serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participants with abnormal physical examination findings</measure>
      <time_frame>One year</time_frame>
      <description>Measure the number of participants with abnormal physical examination findings.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participants with ability to care for themselves, daily activity, and physical activity</measure>
      <time_frame>One year</time_frame>
      <description>Measure the change in participants with Eastern Clinical Oncology Group (ECOG) Scale of Performance Status. The scale is 0-4 with 0 being the fully active (best outcome) and 4 being completely disabled (worst outcome)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participants with abnormal ECG reading</measure>
      <time_frame>One year</time_frame>
      <description>Measure the number of participants with abnormal ECG parameters</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participants with abnormal lab results</measure>
      <time_frame>One year</time_frame>
      <description>Measure the number of participants with abnormal clinical laboratory values</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and two or more recommended doses and schedules for recommended dose expansion (RDEs) of BL-B01D1 in metastatic NSCLC</measure>
      <time_frame>One year</time_frame>
      <description>Determine the highest BL-B01D1 dose level at which ≤33% subjects experience a DLT during the DLT evaluation period and highest BL-B01D1 dose administered in the event and MTD cannot be defined.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cmax of BL-B01D1</measure>
      <time_frame>One year</time_frame>
      <description>Calculate maximum (peak) observed concentration of BL-B01D1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cmax of anti-EGFR×HER3 antibody</measure>
      <time_frame>One year</time_frame>
      <description>Calculate maximum (peak) observed concentration of anti-EGFR×HER3 antibody</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cmax of free payload ED-04</measure>
      <time_frame>One year</time_frame>
      <description>Calculate maximum (peak) observed concentration of free payload ED-04</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax of BL-B01D1</measure>
      <time_frame>One year</time_frame>
      <description>Calculate time of maximum observed concentration of BL-B01D1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax of anti-EGFR×HER3 antibody</measure>
      <time_frame>One year</time_frame>
      <description>Calculate time of maximum observed concentration of anti-EGFR×HER3 antibody</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax of free payload ED-04</measure>
      <time_frame>One year</time_frame>
      <description>Calculate time of maximum observed concentration of free payload ED-04</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC(0-8) of BL-B01D1</measure>
      <time_frame>One year</time_frame>
      <description>Calculate area under the serum concentration-time curve of BL-B01D1 from time 0 to 8 hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC(0-8) of anti-EGFR×HER3 antibodies</measure>
      <time_frame>One year</time_frame>
      <description>Calculate area under the serum concentration-time curve of anti-EGFR×HER3 antibodies from time 0 to 8 hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC(0-8) of free payload ED-04</measure>
      <time_frame>One year</time_frame>
      <description>Calculate area under the serum concentration-time curve of free payload ED-04 from time 0 to 8 hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC(last) of BL-B01D1</measure>
      <time_frame>One year</time_frame>
      <description>Calculate area under the serum concentration-time curve up of BL-B01D1 to the last quantifiable time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC(last) anti-EGFR×HER3 antibodies</measure>
      <time_frame>One year</time_frame>
      <description>Calculate area under the serum concentration-time curve up of anti-EGFR×HER3 antibodies to the last quantifiable time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC(last) of free payload ED-04</measure>
      <time_frame>One year</time_frame>
      <description>Calculate area under the serum concentration-time curve up of free payload ED-04 to the last quantifiable time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Response Rate (ORR)</measure>
      <time_frame>One year</time_frame>
      <description>To assess the clinical efficacy of BL-B01D1 as measured by ORR using RECIST criteria v 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR)</measure>
      <time_frame>One year</time_frame>
      <description>To assess the clinical efficacy of BL-B01D1 as measured by DCR using RECIST criteria v 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time To Response (TTR)</measure>
      <time_frame>One year</time_frame>
      <description>To assess the clinical efficacy of BL-B01D1 as measured by TTR using RECIST criteria v 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-Free Survival (PFS),</measure>
      <time_frame>One year</time_frame>
      <description>To assess the clinical efficacy of BL-B01D1 as measured by PFS using RECIST criteria v 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS).</measure>
      <time_frame>One year</time_frame>
      <description>To assess the clinical efficacy of BL-B01D1 as measured by OS using RECIST criteria v 1.1</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Non Small Cell Lung Cancer</condition>
    <condition>NSCLC</condition>
    <condition>Lung Cancer</condition>
    <arm_group>
      <arm_group_label>BL-B01D1 administered Day 1 and Day 8 per cycle</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>BL-B01D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BL-B01D1 administered Day 1 per cycle</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>BL-B01D1 will be administered on Day 1 via by intravenous infusion every 3 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BL-B01D1</intervention_name>
      <description>The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized.</description>
      <arm_group_label>BL-B01D1 administered Day 1 and Day 8 per cycle</arm_group_label>
      <arm_group_label>BL-B01D1 administered Day 1 per cycle</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signed the informed consent voluntarily and agreed to follow the program requirements&#xD;
  &#xD;
            2. Either sex&#xD;
  &#xD;
            3. Age: ≥18 years&#xD;
  &#xD;
            4. Has a life expectancy of ≥3 months&#xD;
  &#xD;
            5. Has documented locally advanced or metastatic NSCLC, not amenable to curative surgery&#xD;
               or radiation with documentation of radiological disease progression while on/after&#xD;
               receiving most recent treatment regimen for locally advanced or metastatic disease.&#xD;
               Subjects must have received the following treatments based on Actionable Genomic&#xD;
               Alterations (AGA):&#xD;
  &#xD;
                 1. Subjects without AGA: Must have documented negative test results for epidermal&#xD;
                    growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK). Must have no&#xD;
                    known genomic alterations in ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine&#xD;
                    receptor kinase (NTRK), proto-oncogene B-raf (BRAF), mesenchymal-epithelial&#xD;
                    transition (MET) exon 14 skipping, or rearranged during transfection (RET) and&#xD;
                    Kirsten rat sarcoma viral oncogene homolog mutations (KRAS)&#xD;
  &#xD;
                    They must meet 1 of the following prior therapy requirements for locally advanced&#xD;
                    or metastatic NSCLC:&#xD;
  &#xD;
                    Received and refractory to at least one platinum-based chemotherapy with&#xD;
                    α-PD-1/L1 monoclonal antibody given either concurrently or in separate lines of&#xD;
                    therapy. Includes subjects who received prior platinum-based chemotherapy with or&#xD;
                    without radiotherapy with maintenance α-PD-1/L1 monoclonal antibody for Stage 3&#xD;
                    disease and relapsed /progressed within 6 months from the last dose of&#xD;
                    platinum-based chemotherapy. Includes subjects who received prior&#xD;
                    platinum-based/chemotherapy with or without radiotherapy (with or without&#xD;
                    maintenance α-PD-1/L1 monoclonal antibody) for Stage 3 disease and subsequently&#xD;
                    received α-PD-1/L1 monoclonal antibody therapy (with or without platinum-based&#xD;
                    chemotherapy) for recurrent disease. Received platinum-based chemotherapy and&#xD;
                    α-PD-1/L1 monoclonal antibody (in either order) sequentially&#xD;
  &#xD;
                 2. Subjects with AGA must have one or more documented actionable genomic&#xD;
                    alteration(s): EGFR, ALK, ROS1, NTRK, BRAF, KRAS, MET exon 14 skipping, or RET&#xD;
                    and must meet the following for advanced or metastatic NSCLC:&#xD;
  &#xD;
                      -  Subjects must have been treated and refractory with 1 or more prior lines of&#xD;
                         applicable targeted therapy that is locally approved for the participant's&#xD;
                         genomic alteration at the time of screening; subjects who have tumors with&#xD;
                         EGFR L858R or Exon 19 deletion mutations must have received and be&#xD;
                         considered refractory to prior osimertinib therapy. Those who received a&#xD;
                         targeted agent as adjuvant therapy for early-stage disease must have&#xD;
                         relapsed or progressed while on the treatment or within 6 months of the last&#xD;
                         dose OR received at least one additional course of targeted therapy for the&#xD;
                         same genomic alteration (which may or may not be same agent used in the&#xD;
                         adjuvant setting) for relapsed/progressive disease. Subjects who have been&#xD;
                         treated and are refractory to a prior TKI must receive additional approved&#xD;
                         targeted therapy, if locally available and clinically appropriate, for the&#xD;
                         applicable genomic alteration&#xD;
  &#xD;
                      -  Subjects with ROS1, NTRK, BRAF, KRAS, MET exon 14 skipping, or RET must have&#xD;
                         received and be refractory to or be ineligible for at least one&#xD;
                         platinum-based chemotherapy. For subjects with EGFR or ALK prior treatment&#xD;
                         with platinum-based chemotherapy is considered optional. Those who received&#xD;
                         a platinum-containing regimen as adjuvant therapy for early-stage disease&#xD;
                         must have relapsed or progressed while on the treatment or within 6 months&#xD;
                         of the last dose OR received at least one additional course of&#xD;
                         platinum-containing therapy (which may or may not be same as in the adjuvant&#xD;
                         setting) for relapsed/progressive disease and may have received and be&#xD;
                         refractory to one or more α-PD-1/L1 monoclonal antibody alone or in&#xD;
                         combination with a cytotoxic agent&#xD;
  &#xD;
            6. Agree to provide archived tumor samples or fresh samples from primary or metastatic&#xD;
               sites within 2 years; If subjects are unable to provide tumor samples, they will be&#xD;
               admitted after evaluation by the investigator if other admission criteria are met&#xD;
  &#xD;
            7. Has at least one measurable lesion based on RECIST V1.1&#xD;
  &#xD;
            8. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1&#xD;
  &#xD;
            9. Toxicity of previous antitumor therapy has returned to level ≤1 as defined by&#xD;
               NCI-CTCAE V5.0 (except for asymptomatic laboratory abnormalities such as elevated ALP,&#xD;
               hyperuricemia, elevated serum amylase/lipase, and elevated blood glucose; except for&#xD;
               toxicity that the investigator determined to have no safety risk, such as alopecia,&#xD;
               grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement&#xD;
               therapy, etc.)&#xD;
  &#xD;
           10. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%&#xD;
  &#xD;
           11. Has adequate organ function before registration, defined as: a) Marrow Function:&#xD;
               Absolute neutrophil count (ANC) ≥1.2×109 /L, Platelet count ≥100×109 /L, Hemoglobin&#xD;
               (Hb) ≥90 g/L b) Hepatic function: Total bilirubin（TBIL≤1.5 ULN, AST and ALT without&#xD;
               liver metastasis ≤2.5 ULN, AST and ALT with liver metastasis ≤5.0 ULN&#xD;
  &#xD;
           12. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated&#xD;
               partial thromboplastin time (APTT) ≤1.5 ULN&#xD;
  &#xD;
           13. Urinary protein ≤2+ or ≤1000mg/24 hours&#xD;
  &#xD;
           14. For premenopausal women with childbearing potential, a pregnancy test must be taken&#xD;
               within 7 days prior to the start of treatment. Serum or urine pregnancy must be&#xD;
               negative and must be non-lactating. Adequate barrier contraceptive measures should be&#xD;
               taken during the treatment and 6 months after the end of treatment for all subjects&#xD;
               (regardless of gender)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery,&#xD;
               targeted therapy (including small molecule inhibitor of tyrosine kinase), and other&#xD;
               anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the&#xD;
               first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the&#xD;
               first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or&#xD;
               palliative radiotherapy within 2 weeks prior to the first administration&#xD;
  &#xD;
            2. Mixed small-cell lung cancer (SCLC) and NSCLC histology&#xD;
  &#xD;
            3. Subjects with history of severe heart disease, such as: symptomatic congestive heart&#xD;
               failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ Grade 2 heart&#xD;
               failure, history of transmural myocardial infarction, unstable angina pectoris etc&#xD;
  &#xD;
            4. Subjects with prolonged QT interval (QTc &gt;470 msec), complete left bundle branch&#xD;
               block, Grade 3 atrioventricular block&#xD;
  &#xD;
            5. Active autoimmune diseases and inflammatory diseases, such as: systemic lupus&#xD;
               erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis,&#xD;
               inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for Type 1&#xD;
               diabetes, hypothyroidism that can be controlled only by alternative treatment, and&#xD;
               skin diseases that do not require systemic treatment (such as vitiligo, psoriasis)&#xD;
  &#xD;
            6. Other malignant tumors were diagnosed within 5 years prior to the first administration&#xD;
               with the following exceptions: basal cell carcinoma of the skin, squamous cell&#xD;
               carcinoma of the skin and/or carcinoma in situ after radical resection&#xD;
  &#xD;
            7. Subjects with poorly controlled hypertension by two kinds of antihypertensive drugs&#xD;
               (systolic blood pressure&gt;150 mmHg or diastolic blood pressure&gt;100 mmHg)&#xD;
  &#xD;
            8. Subjects have Grade 3 lung disease defined according to NCI-CTCAE v5.0, or a history&#xD;
               of interstitial lung disease (ILD&#xD;
  &#xD;
            9. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and&#xD;
               pulmonary embolism requiring therapeutic intervention within the previous 6 months&#xD;
               before screening; Infusion set-related thrombosis is excluded&#xD;
  &#xD;
           10. Symptoms of active central nervous system metastasis. However, subjects with stable&#xD;
               brain metastasis can be included. Stable is defined as:&#xD;
  &#xD;
                 1. With or without antiepileptic drugs, the seizure-free state lasts for more than&#xD;
                    12 weeks&#xD;
  &#xD;
                 2. There is no need to use glucocorticoids&#xD;
  &#xD;
                 3. Continuous multiple MRI (scanning interval at least 8 weeks) showed a stable&#xD;
                    state in imaging&#xD;
  &#xD;
           11. Subjects who have a history of allergies to recombinant humanized antibodies or human&#xD;
               mouse chimeric antibodies or any of the components of BL-B01D1&#xD;
  &#xD;
           12. Subjects have a history of autologous or allogeneic stem cell transplantation&#xD;
  &#xD;
           13. In the adjuvant (or neoadjuvant) treatment of anthracyclines, the cumulative dose of&#xD;
               anthracyclines is&gt; 360 mg/m2&#xD;
  &#xD;
           14. Known Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis,&#xD;
               active Hepatitis B virus infection (HBV-DNA copy number&gt; the lower limit of detection)&#xD;
               or active Hepatitis C virus infection (HCV antibody positive and HCV-RNA &gt; the lower&#xD;
               limit of detection)&#xD;
  &#xD;
           15. Subjects with active infections requiring systemic treatment, such as severe&#xD;
               pneumonia, bacteremia, sepsis, etc.&#xD;
  &#xD;
           16. Participated in another clinical trial within 4 weeks prior to participating in the&#xD;
               study&#xD;
  &#xD;
           17. Other conditions that the investigator believes that it is not suitable for&#xD;
               participating in this clinical trial&#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>Clinical Leader</last_name>
      <role>Study Director</role>
      <affiliation>SystImmune Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elizabeth D Lotz, MBA</last_name>
      <phone>(425) 453-6841</phone>
      <email>elizabeth.lotz@systimmune.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tara Barrineau</last_name>
      <phone>(425) 453-6841</phone>
      <email>tara.barrineau@systimmune.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hematology/Oncology Associates of Treasure Coast</name>
        <address>
          <city>Port Saint Lucie</city>
          <state>Florida</state>
          <zip>34952</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nicholas Iannotti, MD</last_name>
        <phone>772-408-5159</phone>
        <email>niannotti@hemoncfl.com</email>
      </contact>
      <contact_backup>
        <last_name>Christine Gerdes</last_name>
        <email>cgerdes@hemoncfl.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Prisma Health Cancer Institute</name>
        <address>
          <city>Greenville</city>
          <state>South Carolina</state>
          <zip>29605</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fiona Davidson, RN</last_name>
        <phone>864-455-3600</phone>
        <email>Fiona.Davidson@prismahealth.org</email>
      </contact>
      <contact_backup>
        <last_name>Lisa Johnson, RN</last_name>
        <phone>864-455-3600</phone>
        <email>Lisa.Johnson@prismahealth.org</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT05983432
  org study id: BL-B01D1-LUNG-101
  nct id: NCT05983432
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1
        in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC).
  BL-B01D1-LUNG-101 is a global, multi-center, Phase 1 study to evaluate the safety,
        tolerability, pharmacokinetics , and initial efficacy of BL-B01D1 in participants with
        metastatic or unresectable NSCLC.
  
        This study will be conducted in two different dosing schedules (Cohort A and Cohort B) and
        three parts (dose escalation, dose finding and dose expansion). Cohort A will be dosed on Day
        1 and Day 8 of a continuous 21-day treatment cycle. Cohort B will be dosed on Day 1 of a
        continuous 21-day treatment cycle. Each Cohort has different dose groups.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Participants with Dose-limiting toxicities
  time frame: One year
  description: Measuring the number of patients Dose-limiting toxicities (DLTs). A DLT is defined as any of the following events that are not clearly due to the underlying disease or extraneous causes:
  Hematological toxicities:
  Grade 4 neutrophil count decreased lasting >7 days
  Grade ≥3 febrile neutropenia
  Grade ≥3 platelet count decreased with clinically significant hemorrhage.
  Non-Hematological toxicities:
  Death
  Hy's law cases
  Grade ≥3 non-hematological toxicities,
  measure: Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs),
  time frame: One year
  description: Measuring the number of patients with serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
  measure: Participants with abnormal physical examination findings
  time frame: One year
  description: Measure the number of participants with abnormal physical examination findings.
  measure: Participants with ability to care for themselves, daily activity, and physical activity
  time frame: One year
  description: Measure the change in participants with Eastern Clinical Oncology Group (ECOG) Scale of Performance Status. The scale is 0-4 with 0 being the fully active (best outcome) and 4 being completely disabled (worst outcome)
  measure: Participants with abnormal ECG reading
  time frame: One year
  description: Measure the number of participants with abnormal ECG parameters
  measure: Participants with abnormal lab results
  time frame: One year
  description: Measure the number of participants with abnormal clinical laboratory values
  measure: To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and two or more recommended doses and schedules for recommended dose expansion (RDEs) of BL-B01D1 in metastatic NSCLC
  time frame: One year
  description: Determine the highest BL-B01D1 dose level at which ≤33% subjects experience a DLT during the DLT evaluation period and highest BL-B01D1 dose administered in the event and MTD cannot be defined.
  measure: Cmax of BL-B01D1
  time frame: One year
  description: Calculate maximum (peak) observed concentration of BL-B01D1
  measure: Cmax of anti-EGFR×HER3 antibody
  time frame: One year
  description: Calculate maximum (peak) observed concentration of anti-EGFR×HER3 antibody
  measure: Cmax of free payload ED-04
  time frame: One year
  description: Calculate maximum (peak) observed concentration of free payload ED-04
  measure: Tmax of BL-B01D1
  time frame: One year
  description: Calculate time of maximum observed concentration of BL-B01D1
  measure: Tmax of anti-EGFR×HER3 antibody
  time frame: One year
  description: Calculate time of maximum observed concentration of anti-EGFR×HER3 antibody
  measure: Tmax of free payload ED-04
  time frame: One year
  description: Calculate time of maximum observed concentration of free payload ED-04
  measure: AUC(0-8) of BL-B01D1
  time frame: One year
  description: Calculate area under the serum concentration-time curve of BL-B01D1 from time 0 to 8 hours
  measure: AUC(0-8) of anti-EGFR×HER3 antibodies
  time frame: One year
  description: Calculate area under the serum concentration-time curve of anti-EGFR×HER3 antibodies from time 0 to 8 hours
  measure: AUC(0-8) of free payload ED-04
  time frame: One year
  description: Calculate area under the serum concentration-time curve of free payload ED-04 from time 0 to 8 hours
  measure: AUC(last) of BL-B01D1
  time frame: One year
  description: Calculate area under the serum concentration-time curve up of BL-B01D1 to the last quantifiable time
  measure: AUC(last) anti-EGFR×HER3 antibodies
  time frame: One year
  description: Calculate area under the serum concentration-time curve up of anti-EGFR×HER3 antibodies to the last quantifiable time
  measure: AUC(last) of free payload ED-04
  time frame: One year
  description: Calculate area under the serum concentration-time curve up of free payload ED-04 to the last quantifiable time
  measure: Overall Response Rate (ORR)
  time frame: One year
  description: To assess the clinical efficacy of BL-B01D1 as measured by ORR using RECIST criteria v 1.1
  measure: Disease Control Rate (DCR)
  time frame: One year
  description: To assess the clinical efficacy of BL-B01D1 as measured by DCR using RECIST criteria v 1.1
  measure: Time To Response (TTR)
  time frame: One year
  description: To assess the clinical efficacy of BL-B01D1 as measured by TTR using RECIST criteria v 1.1
  measure: Progression-Free Survival (PFS),
  time frame: One year
  description: To assess the clinical efficacy of BL-B01D1 as measured by PFS using RECIST criteria v 1.1
  measure: Overall Survival (OS).
  time frame: One year
  description: To assess the clinical efficacy of BL-B01D1 as measured by OS using RECIST criteria v 1.1
  arm group label: BL-B01D1 administered Day 1 and Day 8 per cycle
  arm group type: Experimental
  description: BL-B01D1 will be administered on Day 1 and Day 8 by intravenous infusion every 3 weeks
  arm group label: BL-B01D1 administered Day 1 per cycle
  arm group type: Experimental
  description: BL-B01D1 will be administered on Day 1 via by intravenous infusion every 3 weeks
  intervention type: Drug
  intervention name: BL-B01D1
  description: The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized.
  arm group label: BL-B01D1 administered Day 1 and Day 8 per cycle
  arm group label: BL-B01D1 administered Day 1 per cycle
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clinical Leader
  role: Study Director
  affiliation: SystImmune Inc.
  last name: Elizabeth D Lotz, MBA
  phone: (425) 453-6841
  email: elizabeth.lotz@systimmune.com
  last name: Tara Barrineau
  phone: (425) 453-6841
  email: tara.barrineau@systimmune.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  sharing ipd: No