<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/NCT04501770</url>
  </required_header>
  <id_info>
    <org_study_id>M802001</org_study_id>
    <nct_id>NCT04501770</nct_id>
  </id_info>
  <brief_title>A Study of M802 (HER2 and CD3) in HER2-Positive Advanced Solid Tumors</brief_title>
  <official_title>A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity Profiles of the Recombinant Anti-HER2 and Anti-CD3 Humanized Bispecific Antibody (M802) in HER2-Positive Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan YZY Biopharma Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wuhan YZY Biopharma Co., Ltd.</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 purpose of this study is to evaluate the safety and tolerability of different doses of&#xD;
      M802 in patients with HER2-positive advanced solid tumors, and to determine the dose limiting&#xD;
      toxicity (DLT) and the maximum tolerated dose (MTD) so as to provide basis for the&#xD;
      recommended phase 2 dose (RP2D).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">August 28, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2023</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>MTD</measure>
    <time_frame>From the time of first dosing (Day 1) until the forth dosing (Day 28)</time_frame>
    <description>Number of DLTs (dose limiting toxicities) during the first 28 days after the first administrations of study drug in each cohort.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RP2D</measure>
    <time_frame>From the start of administration to the end of the study or 28 days after the administration is stopped (up to 1 years and 28 days)</time_frame>
    <description>Incidence and severity of AEs, and SAEs, including but not limited to laboratory values, PK and biomarkers. All AEs will be classified as Grades 1 through 5 as defined by NCI CTCAE v5.0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the curve (AUC) of M802</measure>
    <time_frame>From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).</time_frame>
    <description>The endpoints for assessment of PK of M802 include serum concentrations of M802 at different timepoints after M802 administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed concentration (Cmax) of M802</measure>
    <time_frame>From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).</time_frame>
    <description>The endpoints for assessment of PK of M802 include serum concentrations of M802 at different timepoints after M802 administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum observed concentration (Cmin) of M802</measure>
    <time_frame>From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).</time_frame>
    <description>The endpoints for assessment of PK of M802 include serum concentrations of M802 at different timepoints after M802 administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expression levels of CEA</measure>
    <time_frame>From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).</time_frame>
    <description>As tumor marker, expression levels of CEA will be tested in hospitals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expression levels of CA15-3</measure>
    <time_frame>From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).</time_frame>
    <description>As tumor marker, expression levels of CA15-3 will be tested in hospitals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expression levels of CA125</measure>
    <time_frame>From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).</time_frame>
    <description>As tumor marker, expression levels of CA125 will be tested in hospitals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expression levels of CA19-9</measure>
    <time_frame>From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).</time_frame>
    <description>As tumor marker, expression levels of CA19-9 will be tested in hospitals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expression levels of CA72-4</measure>
    <time_frame>From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).</time_frame>
    <description>As tumor marker, expression levels of CA72-4 will be tested in hospitals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokines</measure>
    <time_frame>From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).</time_frame>
    <description>The levels of pharmacodynamic cytokines will be determined at the PD central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects who develop detectable anti-drug antibodies (ADAs)</measure>
    <time_frame>From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).</time_frame>
    <description>The immunogenicity of M802 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The antibody titer of the neutralizing antibody</measure>
    <time_frame>From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).</time_frame>
    <description>The immunogenicity of M802 will be collected by testing the antibody titer of the neutralizing antibody.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).</time_frame>
    <description>Objective response rate (ORR) is defined as the proportion of patients with complete response (CR) and partial response (PR), based on RECIST Version 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).</time_frame>
    <description>Disease Control Rate (DCR) is defined as the proportion of patients with complete response (CR) and partial response (PR), based on RECIST Version 1.1.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>HER2-Positive Solid Tumors</condition>
  <arm_group>
    <arm_group_label>M802</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects who meet the enrollment criteria will enter the core treatment period and receive a cycle of treatment with M802 (once weekly for 4 weeks) via intravenous infusion. And eligible subjects who complete the core treatment period will receive a cycle of extended treatment (once weekly for 4 weeks) until disease progression or toxicity intolerance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chort 1 of M802</intervention_name>
    <description>Cohort 1, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 2 μg, and the maintenance dose during core treatment period and extended treatment period is 5 μg.</description>
    <arm_group_label>M802</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chort 2 of M802</intervention_name>
    <description>Cohort 2, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 5 μg, and the maintenance dose during core treatment period and extended treatment period is 10 μg.</description>
    <arm_group_label>M802</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cohort 3 of M802</intervention_name>
    <description>Cohort 3, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 10 μg, and the maintenance dose during core treatment period and extended treatment period is 20 μg.</description>
    <arm_group_label>M802</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cohort 4 of M802</intervention_name>
    <description>Cohort 4, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 20 μg, and the maintenance dose during core treatment period and extended treatment period is 50 μg.</description>
    <arm_group_label>M802</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cohort 5 of M802</intervention_name>
    <description>Cohort 5, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 50 μg, and the maintenance dose during core treatment period and extended treatment period is 100 μg.</description>
    <arm_group_label>M802</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cohort 6 of M802</intervention_name>
    <description>Cohort 6, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 100 μg, and the maintenance dose during core treatment period and extended treatment period is 150 μg.</description>
    <arm_group_label>M802</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cohort 7 of M802</intervention_name>
    <description>Cohort 7, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1 is 150 μg, and on D8, D15, D22 is 225 μg.</description>
    <arm_group_label>M802</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cohort 8 of M802</intervention_name>
    <description>Cohort 8, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 225 μg, and the maintenance dose during core treatment period and extended treatment period is 300 μg.</description>
    <arm_group_label>M802</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females, aged ≥18 years old.&#xD;
&#xD;
          2. Patients must have a diagnosis of histologically or cytologically confirmed metastatic&#xD;
             advanced solid tumor with failure to standard treatment and who have no available&#xD;
             therapy that may confer clinical benefit. Patients with HER2-positive metastatic&#xD;
             breast cancer should have received standard anti-HER2 therapies.&#xD;
&#xD;
          3. HER2 expression status report should be provided during the screening period with&#xD;
             fluorescence in-situ hybridization (FISH) or Chromogenic in situ hybridization (CISH)&#xD;
             test positive, or immunohistochemistry IHC 3+, or immunohistochemistry IHC 2+ and&#xD;
             confirmed by amplification of FISH or CISH.&#xD;
&#xD;
          4. Patients must have stopped anti-tumor treatment for at least 4 weeks prior to the&#xD;
             first dose of M802. The anti-tumor treatment includes chemotherapy, immunotherapy,&#xD;
             targeted therapy, endocrine therapy, and radiotherapy (except for local radiation&#xD;
             therapy for alleviating pain, at least 14 days after end of treatment).&#xD;
&#xD;
          5. Patients must have measurable lesions at baseline according to the RECIST Version 1.1.&#xD;
&#xD;
          6. Patients must have an ECOG performance status (PS) Score of 0-1.&#xD;
&#xD;
          7. Patients must have an expected survival &gt; 12 weeks.&#xD;
&#xD;
          8. Patients must have a baseline left ventricular ejection fraction (LVEF) ≥ 50%.&#xD;
&#xD;
          9. Patients must have adequate haematological and organ functions as indicated by the&#xD;
             following laboratory values:&#xD;
&#xD;
             Haematological: Absolute Neutrophil Count (ANC) ≥ 1.5 ×10^9/L; Blood Platelet Count&#xD;
             (BPC) ≥ 80 ×10^9/L; Hemoglobin ≥ 9.0 g/dL (No blood transfusions within 14 days).&#xD;
&#xD;
             Hepatic: Bilirubin ≤ 1.5 × upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN (AST,&#xD;
             ALT ≤ 5 × ULN is allowed when there is liver metastasis).&#xD;
&#xD;
             Renal: Serum creatinine ≤ 1.5 × ULN.&#xD;
&#xD;
         10. Patients must understand and voluntarily agree to participate by signing written&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who had prior treatment with trastuzumab or similar monoclonal drugs within 4&#xD;
             weeks before first dosing of M802.&#xD;
&#xD;
          2. Patients with brain metastasis.&#xD;
&#xD;
          3. Patients who have uncontrollable active infections (Grade ≥ 2 according to CTCAE&#xD;
             Version 5.0).&#xD;
&#xD;
          4. Patients with severe respiratory disease who are not suitable for the study at the&#xD;
             judgment of investigator.&#xD;
&#xD;
          5. Patients with severe immunosuppression (long-term use of immunosuppressant or&#xD;
             glucocorticoid with daily dosage of dexamethasone ≥10 mg).&#xD;
&#xD;
          6. Patients who have other malignant tumors in the past 5 years, except the complete&#xD;
             cured cervical carcinoma in situ or basal cell or squamous cell carcinoma.&#xD;
&#xD;
          7. Patients with a history of serious cardiovascular disease, including receiving&#xD;
             coronary artery bypass grafts or coronary stenting, occurrence of myocardial&#xD;
             infarction, congestive heart failure within 6 months, or a history of unstable angina,&#xD;
             uncontrolled severe hypertension or arrhythmia requiring medication.&#xD;
&#xD;
          8. Patients with a history of autoimmune diseases (e.g. inflammatory bowel disease,&#xD;
             idiopathic thrombocytopenic purpura, lupus erythematosus, hemolytic anemia,&#xD;
             scleroderma, severe psoriasis, rheumatoid arthritis).&#xD;
&#xD;
          9. Patients with severe hyperthyroidism or hypothyroidism.&#xD;
&#xD;
         10. Patients with metabolic diseases such as uncontrolled diabetes, severe&#xD;
             gastrointestinal bleeding, severe diarrhea (Grade ≥ 2 according to CTCAE Version 5.0),&#xD;
             or severe gastrointestinal obstruction requiring intervention.&#xD;
&#xD;
         11. Patients with a history of immunodeficiency, including HIV positive.&#xD;
&#xD;
         12. Patients with Hepatitis b surface antigen test positive or hepatitis c antibody test&#xD;
             positive.&#xD;
&#xD;
         13. Patients who have received inoculation of (attenuated) live virus vaccine within 4&#xD;
             weeks before first dosing of M802.&#xD;
&#xD;
         14. Pregnant, lactating women, or females or males who have fertility plan within 12&#xD;
             months.&#xD;
&#xD;
         15. Patients with a previous history of definite neurological or psychiatric disorders,&#xD;
             including epilepsy or dementia.&#xD;
&#xD;
         16. Patients who participated in clinical studies of other drugs within 4 weeks prior to&#xD;
             first dosing of M802 (using last dosing of other drug's clinical studies as end).&#xD;
&#xD;
         17. Patients with adverse reactions from previous treatment haven't recovered to grade 1&#xD;
             according to CTCAE Version 5.0 (except for residual effect on hair loss).&#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_contact>
    <last_name>Xiong Wang</last_name>
    <phone>86-027-82668440</phone>
    <email>wangxiong@yzybio.com</email>
  </overall_contact>
  <removed_countries>
    <country>China</country>
  </removed_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>July 28, 2021</last_update_submitted>
  <last_update_submitted_qc>July 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2021</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>


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/NCT04501770
org study id: M802001
nct id: NCT04501770
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety and tolerability of different doses of
      M802 in patients with HER2-positive advanced solid tumors, and to determine the dose limiting
      toxicity (DLT) and the maximum tolerated dose (MTD) so as to provide basis for the
      recommended phase 2 dose (RP2D).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MTD
time frame: From the time of first dosing (Day 1) until the forth dosing (Day 28)
description: Number of DLTs (dose limiting toxicities) during the first 28 days after the first administrations of study drug in each cohort.
measure: RP2D
time frame: From the start of administration to the end of the study or 28 days after the administration is stopped (up to 1 years and 28 days)
description: Incidence and severity of AEs, and SAEs, including but not limited to laboratory values, PK and biomarkers. All AEs will be classified as Grades 1 through 5 as defined by NCI CTCAE v5.0.
measure: Area under the curve (AUC) of M802
time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
description: The endpoints for assessment of PK of M802 include serum concentrations of M802 at different timepoints after M802 administration.
measure: Maximum observed concentration (Cmax) of M802
time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
description: The endpoints for assessment of PK of M802 include serum concentrations of M802 at different timepoints after M802 administration.
measure: Minimum observed concentration (Cmin) of M802
time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
description: The endpoints for assessment of PK of M802 include serum concentrations of M802 at different timepoints after M802 administration.
measure: Expression levels of CEA
time frame: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
description: As tumor marker, expression levels of CEA will be tested in hospitals.
measure: Expression levels of CA15-3
time frame: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
description: As tumor marker, expression levels of CA15-3 will be tested in hospitals.
measure: Expression levels of CA125
time frame: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
description: As tumor marker, expression levels of CA125 will be tested in hospitals.
measure: Expression levels of CA19-9
time frame: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
description: As tumor marker, expression levels of CA19-9 will be tested in hospitals.
measure: Expression levels of CA72-4
time frame: From the time of screening period until disease progression or toxicity intolerance (up to 1 years and 28 days).
description: As tumor marker, expression levels of CA72-4 will be tested in hospitals.
measure: Cytokines
time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
description: The levels of pharmacodynamic cytokines will be determined at the PD central laboratory.
measure: Number of subjects who develop detectable anti-drug antibodies (ADAs)
time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
description: The immunogenicity of M802 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
measure: The antibody titer of the neutralizing antibody
time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
description: The immunogenicity of M802 will be collected by testing the antibody titer of the neutralizing antibody.
measure: ORR
time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
description: Objective response rate (ORR) is defined as the proportion of patients with complete response (CR) and partial response (PR), based on RECIST Version 1.1.
measure: DCR
time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 1 years).
description: Disease Control Rate (DCR) is defined as the proportion of patients with complete response (CR) and partial response (PR), based on RECIST Version 1.1.
arm group label: M802
arm group type: Experimental
description: Subjects who meet the enrollment criteria will enter the core treatment period and receive a cycle of treatment with M802 (once weekly for 4 weeks) via intravenous infusion. And eligible subjects who complete the core treatment period will receive a cycle of extended treatment (once weekly for 4 weeks) until disease progression or toxicity intolerance.
intervention type: Drug
intervention name: Chort 1 of M802
description: Cohort 1, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 2 μg, and the maintenance dose during core treatment period and extended treatment period is 5 μg.
arm group label: M802
intervention type: Drug
intervention name: Chort 2 of M802
description: Cohort 2, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 5 μg, and the maintenance dose during core treatment period and extended treatment period is 10 μg.
arm group label: M802
intervention type: Drug
intervention name: Cohort 3 of M802
description: Cohort 3, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 10 μg, and the maintenance dose during core treatment period and extended treatment period is 20 μg.
arm group label: M802
intervention type: Drug
intervention name: Cohort 4 of M802
description: Cohort 4, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 20 μg, and the maintenance dose during core treatment period and extended treatment period is 50 μg.
arm group label: M802
intervention type: Drug
intervention name: Cohort 5 of M802
description: Cohort 5, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 50 μg, and the maintenance dose during core treatment period and extended treatment period is 100 μg.
arm group label: M802
intervention type: Drug
intervention name: Cohort 6 of M802
description: Cohort 6, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 100 μg, and the maintenance dose during core treatment period and extended treatment period is 150 μg.
arm group label: M802
intervention type: Drug
intervention name: Cohort 7 of M802
description: Cohort 7, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1 is 150 μg, and on D8, D15, D22 is 225 μg.
arm group label: M802
intervention type: Drug
intervention name: Cohort 8 of M802
description: Cohort 8, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 225 μg, and the maintenance dose during core treatment period and extended treatment period is 300 μg.
arm group label: M802
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xiong Wang
phone: 86-027-82668440
email: wangxiong@yzybio.com
country: China
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No