<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/NCT04412616</url>
  </required_header>
  <id_info>
    <org_study_id>ZZ06-2020A</org_study_id>
    <nct_id>NCT04412616</nct_id>
  </id_info>
  <brief_title>ZZ06 in Adult Patients With Advanced EGFR Positive Solid Tumor Malignancies</brief_title>
  <official_title>A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Evidence of Antitumor Activity of ZZ06 in Adult Patients With Advanced EGFR Positive Solid Tumor Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changchun Intellicrown Pharmaceutical Co. LTD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Covance</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Changchun Intellicrown Pharmaceutical Co. LTD</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1, Multicenter, Open-label study to assess the safety, tolerability and&#xD;
      preliminary efficacy of ZZ06 in participants with all Adult Patients with Advanced&#xD;
      EGFR-positive Solid Tumor Malignancies who are not able to have current standard anti-tumor&#xD;
      therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) , to&#xD;
      characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and&#xD;
      anti-tumor activity of ZZ06 as a single agent in adult participants with advanced solid&#xD;
      tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will start with an accelerated-titration dose escalation scheme, enrolling 1&#xD;
      patient per cohort for the first 2 cohorts with expansion to 3 patients in the event of Grade&#xD;
      ≥ 2 treatment-emergent adverse event (TEAE) or dose limiting toxicity (DLT) possibly,&#xD;
      probably, or definitely related to the study drug. After the first 2 cohorts, the study will&#xD;
      then proceed to a 3+3 design, with enrollment of 3 patients per cohort and expansion to 6&#xD;
      patients in the event of a DLT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">April 6, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <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>ZZ06 AEs</measure>
    <time_frame>up to 36 weeks</time_frame>
    <description>Adverse events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of abnormal laboratory test results</measure>
    <time_frame>up to 36 weeks</time_frame>
    <description>The data of the clinical laboratory evaluation is collected and analyzed according to the time point of the test flow chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of abnormal physical exam findings</measure>
    <time_frame>up to 36 weeks</time_frame>
    <description>The data of the physical examinations is collected and analyzed according to the time point of the test flow chart</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK parameters: Area under curve (AUC)</measure>
    <time_frame>up to 28 weeks</time_frame>
    <description>According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters: Cmax</measure>
    <time_frame>up to 28 weeks</time_frame>
    <description>According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters: Clearance rate (CL)</measure>
    <time_frame>up to 28 weeks</time_frame>
    <description>According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters: t1/2</measure>
    <time_frame>up to 28 weeks</time_frame>
    <description>According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameters: Vz</measure>
    <time_frame>up to 28 weeks</time_frame>
    <description>According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Advanced EGFR Positive Solid Tumor</condition>
  <arm_group>
    <arm_group_label>ZZ06 0.03 mg/kg dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ZZ06 0.03 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ZZ06 0.06 mg/kg dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ZZ06 0.06 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ZZ06 0.12 mg/kg dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ZZ06 0.12 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ZZ06 0.22 mg/kg dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ZZ06 0.22 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ZZ06 0.39 mg/kg dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ZZ06 0.39 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ZZ06 0.70 mg/kg dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ZZ06 0.70 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ZZ06 1.00 mg/kg dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ZZ06 1.00 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ZZ06</intervention_name>
    <description>The phase I &quot;3 + 3&quot; study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1 mg/kg.</description>
    <arm_group_label>ZZ06 0.03 mg/kg dose group</arm_group_label>
    <arm_group_label>ZZ06 0.06 mg/kg dose group</arm_group_label>
    <arm_group_label>ZZ06 0.12 mg/kg dose group</arm_group_label>
    <arm_group_label>ZZ06 0.22 mg/kg dose group</arm_group_label>
    <arm_group_label>ZZ06 0.39 mg/kg dose group</arm_group_label>
    <arm_group_label>ZZ06 0.70 mg/kg dose group</arm_group_label>
    <arm_group_label>ZZ06 1.00 mg/kg dose group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically or cytologically confirmed advanced solid tumor that is&#xD;
             positive for EGFR and has progressed despite standard therapy or for whom no standard&#xD;
             therapy exists.&#xD;
&#xD;
          -  Patients are required to have archival tumor tissue available for assessment of EGFR&#xD;
             status via FDA-approved EGFR assay .&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Patients must have at least 1 measurable lesion as defined by RECIST v1.1.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status of 0 or 1.&#xD;
&#xD;
          -  Life expectancy ≥ 12 weeks.&#xD;
&#xD;
          -  Baseline organ function and laboratory data meet the following criteria:&#xD;
&#xD;
               1. Bone marrow： ANC ≥ 1500 cells/mm3； Platelet count ≥ 75 000 cells/mm3； Hemoglobin&#xD;
                  ≥ 8.0 g/dL.&#xD;
&#xD;
               2. Coagulation： Prothrombin time ≤ 1.5× ULN； Activated partial thromboplastin time ≤&#xD;
                  1.5× ULN；&#xD;
&#xD;
               3. Renal function： Serum creatinine ≤ 1.5× ULN ； estimated glomerular filtration&#xD;
                  rate≥ 60 mL/min (Cockcroft-Gault formula).&#xD;
&#xD;
               4. Hepatic function： Serum total bilirubin ≤ 1.5 mg/dL； AST and ALT ≤ 3.0× ULN (if&#xD;
                  metastases are present, ≤ 5.0× ULN).&#xD;
&#xD;
          -  Females will not be pregnant or lactating, and females of childbearing potential and&#xD;
             males will agree to use contraception.Patients must provide written informed consent&#xD;
             prior to any study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of another primary cancer ≤ 3 years, with the exception of completely resected&#xD;
             nonmelanoma skin cancer or carcinoma in situ of uterine cervix.&#xD;
&#xD;
          -  Active or symptomatic CNS metastases. Patients with treated CNS metastases that have&#xD;
             been stable for ≥ 4 weeks and do not require treatment with steroids or&#xD;
             anticonvulsants may be enrolled at the discretion of the Investigator.&#xD;
&#xD;
          -  Tests positive for hepatitis C virus, hepatitis B virus, or human immunodeficiency&#xD;
             virus infection.&#xD;
&#xD;
          -  Active, clinically significant infections.&#xD;
&#xD;
          -  Clinically significant cardiovascular disease, including any of the following:&#xD;
&#xD;
               1. Congestive heart failure (New York Heart Association Class &gt; 2).&#xD;
&#xD;
               2. Serious cardiac arrhythmia.&#xD;
&#xD;
               3. Myocardial infarction ≤ 6 months.&#xD;
&#xD;
               4. Unstable angina.&#xD;
&#xD;
          -  Prior clinically significant allergic reaction to chimerized or murine monoclonal&#xD;
             antibody therapy.&#xD;
&#xD;
          -  Prior treatment ≤ 6 months with cetuximab, panitumomab, gefitinb, erlotinib, or other&#xD;
             therapy that specifically and directly targets the EGF pathway.&#xD;
&#xD;
          -  Anticancer therapy or investigational agents for nonmalignant disease ≤ 4 weeks or 5&#xD;
             half-lives, whichever is shorter, prior to Cycle 1 Day 1, with the exception of&#xD;
             tamoxifen for patients with a history of operated breast cancer &gt; 3 years and no&#xD;
             evidence of disease after surgery.&#xD;
&#xD;
          -  Major surgery ≤ 4 weeks.&#xD;
&#xD;
          -  Clinically significant psychiatric illness, other comorbidity, or laboratory&#xD;
             abnormality that, in the opinion of the Investigator, makes it unsafe for the patient&#xD;
             to participate in the study or may interfere with study compliance or study results.&#xD;
&#xD;
          -  Other unspecified reasons that, in the opinion of the Investigator, make the patient&#xD;
             unsuitable for enrollment.&#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>Sanjay Goel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shiqi Bai</last_name>
    <phone>18943642700</phone>
    <email>baishiqi@intelli-crown.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048-1804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Monica Mita, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kansas University Cancer Center</name>
      <address>
        <city>Fairway</city>
        <state>Kansas</state>
        <zip>66205-2528</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joaquina Baranda, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>90048-1804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sanjay Goel, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jilin Cancer Hospital</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ying Cheng, BMed</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>treatment-emergent adverse event (TEAE)</keyword>
  <keyword>dose limiting toxicity (DLT)</keyword>
  <keyword>pharmacokinetic (PK)</keyword>
  <keyword>antidrug antibodies (ADA)</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>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/NCT04412616
org study id: ZZ06-2020A
nct id: NCT04412616
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1, Multicenter, Open-label study to assess the safety, tolerability and
      preliminary efficacy of ZZ06 in participants with all Adult Patients with Advanced
      EGFR-positive Solid Tumor Malignancies who are not able to have current standard anti-tumor
      therapies. The purpose of this study is to determine the maximum tolerated dose (MTD) , to
      characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and
      anti-tumor activity of ZZ06 as a single agent in adult participants with advanced solid
      tumors.
The study will start with an accelerated-titration dose escalation scheme, enrolling 1
      patient per cohort for the first 2 cohorts with expansion to 3 patients in the event of Grade
      ≥ 2 treatment-emergent adverse event (TEAE) or dose limiting toxicity (DLT) possibly,
      probably, or definitely related to the study drug. After the first 2 cohorts, the study will
      then proceed to a 3+3 design, with enrollment of 3 patients per cohort and expansion to 6
      patients in the event of a DLT.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ZZ06 AEs
time frame: up to 36 weeks
description: Adverse events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
measure: Incidence of abnormal laboratory test results
time frame: up to 36 weeks
description: The data of the clinical laboratory evaluation is collected and analyzed according to the time point of the test flow chart
measure: Incidence of abnormal physical exam findings
time frame: up to 36 weeks
description: The data of the physical examinations is collected and analyzed according to the time point of the test flow chart
measure: PK parameters: Area under curve (AUC)
time frame: up to 28 weeks
description: According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
measure: PK parameters: Cmax
time frame: up to 28 weeks
description: According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
measure: PK parameters: Clearance rate (CL)
time frame: up to 28 weeks
description: According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
measure: PK parameters: t1/2
time frame: up to 28 weeks
description: According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
measure: PK parameters: Vz
time frame: up to 28 weeks
description: According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
arm group label: ZZ06 0.03 mg/kg dose group
arm group type: Experimental
description: ZZ06 0.03 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
arm group label: ZZ06 0.06 mg/kg dose group
arm group type: Experimental
description: ZZ06 0.06 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
arm group label: ZZ06 0.12 mg/kg dose group
arm group type: Experimental
description: ZZ06 0.12 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
arm group label: ZZ06 0.22 mg/kg dose group
arm group type: Experimental
description: ZZ06 0.22 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
arm group label: ZZ06 0.39 mg/kg dose group
arm group type: Experimental
description: ZZ06 0.39 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
arm group label: ZZ06 0.70 mg/kg dose group
arm group type: Experimental
description: ZZ06 0.70 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
arm group label: ZZ06 1.00 mg/kg dose group
arm group type: Experimental
description: ZZ06 1.00 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
intervention type: Biological
intervention name: ZZ06
description: The phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1 mg/kg.
arm group label: ZZ06 0.03 mg/kg dose group
arm group label: ZZ06 0.06 mg/kg dose group
arm group label: ZZ06 0.12 mg/kg dose group
arm group label: ZZ06 0.22 mg/kg dose group
arm group label: ZZ06 0.39 mg/kg dose group
arm group label: ZZ06 0.70 mg/kg dose group
arm group label: ZZ06 1.00 mg/kg dose group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sanjay Goel, MD
role: Principal Investigator
affiliation: Montefiore Medical Center
last name: Shiqi Bai
phone: 18943642700
email: baishiqi@intelli-crown.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: China
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No