<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/NCT04450732</url>
  </required_header>
  <id_info>
    <org_study_id>GQ1001X2101</org_study_id>
    <nct_id>NCT04450732</nct_id>
  </id_info>
  <brief_title>Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors</brief_title>
  <official_title>A Phase 1, First-In-Human, Multicenter, Open-Label, Study of GQ1001, a HER2 Targeted Antibody-Drug Conjugate, Administered Intravenously, in Adult Patients With HER2-Positive Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GeneQuantum Healthcare (Suzhou) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GeneQuantum Healthcare (Suzhou) Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2024</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>
    <intervention_model_description>Modified 3+3 Design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose Limiting Toxicities (DLTs).</measure>
    <time_frame>End of Cycle 1 (21-day cycle)</time_frame>
    <description>Adverse events will be assessed using NCI CTCAE version 5.0 and will be evaluated by the investigator and the sponsor for the eligibility of DLT.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Tolerated Dose (MTD) or Dose Recommended for Dose Expansion (DRDE)</measure>
    <time_frame>After each cohort completes the DLT observation period (Day 1 to Day 21 after the first dose of study treatment) or has a DLT or becomes not DLT-evaluable</time_frame>
    <description>The SRC will also determine the MTD/DRDE based on the totality of data for all tested dose levels.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and Severity of Adverse Events (AEs)</measure>
    <time_frame>from baseline to 30 days after last dose</time_frame>
    <description>Safety and Tolerability of GQ1001</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Abnormal Laboratory Values</measure>
    <time_frame>rom baseline through Cycle 8 (each cycle is 21 days) and up to 30 days from treatment discontinuationafter last dose</time_frame>
    <description>Safety and Tolerability of GQ1001</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration Versus Time Curve (AUC) of GQ1001</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Plasma Concentration of GQ1001 (Cmax)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time at which the Cmax is Observed (Tmax)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half Life of GQ1001 (T1/2)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Residence Time of GQ1001 (MRT)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution of GQ1001 (Vd)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preliminary Efficacy of GQ1001 Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and CT of MRI scans</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Anti-GQ1001 antibody/anti-therapeutic antibody</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preliminary Efficacy</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>objective response rate (ORR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preliminary Efficacy</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>disease control rate (DCR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preliminary Efficacy</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>duration of response (DoR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preliminary Efficacy</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>progression-free survival (PFS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>HER2-positive Breast Cancer</condition>
  <condition>HER2-positive Biliary Tract Cancer</condition>
  <condition>HER2-Positive Salivary Gland Carcinomas</condition>
  <condition>HER2-Positive Advanced Solid Tumor</condition>
  <arm_group>
    <arm_group_label>Dose Escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GQ1001 will be administered intravenously every 21 days. Dose Escalation will be guided by a modified 3+3 design.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GQ1001 at the Dose Recommended for Dose Expansion will be administered intravenously every 21 days. Dose expansion will further evaluate the MTD or DRDE in different types of malignant solid tumor in four cohorts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GQ1001</intervention_name>
    <description>anti-HER2 antibody drug conjugate</description>
    <arm_group_label>Dose Escalation</arm_group_label>
    <arm_group_label>Dose Expansion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent form and able to comply with the protocol;&#xD;
&#xD;
          2. Male and female subjects ≥18 years of age;&#xD;
&#xD;
          3. ECOG PS of 0 or 1, the estimated life expectancy ≥ 3 months;&#xD;
&#xD;
          4. LVEF ≥ 50% as determined by echocardiography (ECHO);&#xD;
&#xD;
          5. Patients must have pathologically documented advanced/unresectable or metastatic solid&#xD;
             tumor with HER2-positive (as defined below) that is relapsed or refractory to standard&#xD;
             therapy or for which there is no standard therapy and progressed. Patients must have a&#xD;
             least one measurable disease lesion. Tumor specimens to identify HER2 status should be&#xD;
             obtained within the past 6 months.&#xD;
&#xD;
             Definition of HER2-positive&#xD;
&#xD;
               -  Advanced/unresectable or metastatic breast cancer: immunohistochemistry (IHC) 3+,&#xD;
                  or IHC 2+ and in situ hybridization positive (ISH+)*;&#xD;
&#xD;
               -  Advanced/unresectable or metastatic gastric or gastroesophageal junction&#xD;
                  adenocarcinoma: IHC 3+, or IHC 2+ and ISH+*;&#xD;
&#xD;
               -  Other HER2-positive advanced/unresectable or metastatic solid malignant tumor:&#xD;
                  determined by IHC, ISH, Next Generation Sequencing, or other analysis techniques&#xD;
                  as appropriate;&#xD;
&#xD;
                    -  ISH: fluorescence in situ hybridization (FISH) or dual in situ hybridization&#xD;
                       (DISH); ISH positivity is defined as a ratio of ≥ 2.0 for the number of HER2&#xD;
                       gene copies to the number of signals for CEP17. ISH assay is not required&#xD;
                       when IHC result is 3+. ISH assay should be performed to confirm HER2&#xD;
                       positivity when IHC result is 2+.&#xD;
&#xD;
          6. Adequate organ function confirmed at screening and within 7 days before the first&#xD;
             treatment, as evidenced by:&#xD;
&#xD;
             Platelet count: ≥ 100,000/mm3 ; Hemoglobin : ≥ 9 g/dL; Absolute neutrophil count&#xD;
             (ANC): ≥ 1500/mm3 ; Serum creatinine: ≤ 1.5 × ULN (upper limit of normal), or&#xD;
             creatinine clearance ≥ 60 mL/min (using Cockcroft Gault formula) ; Aspartate&#xD;
             aminotransferase (AST)/alanine aminotransferase (ALT) : ≤ 2.5 × ULN (≤ 5 × ULN if&#xD;
             liver metastases are present); Total bilirubin : ≤ 1.5 × ULN (except for patients with&#xD;
             Gilbert's Syndrome); Prothrombin time and activated partial thromboplastin time: ≤ 1.5&#xD;
             × ULN.&#xD;
&#xD;
          7. Adequate washout period before the first treatment as defined by:&#xD;
&#xD;
             Major surgery: ≥ 4 weeks. Radiation therapy: ≥ 4 weeks (≥ 2 weeks for palliative&#xD;
             stereotactic radiation therapy without abdominal). Autologous transplantation: ≥ 3&#xD;
             months.&#xD;
&#xD;
             Hormonal therapy: ≥ 2 weeks or per Investigator's discretion for breast cancer&#xD;
             patients.&#xD;
&#xD;
             Chemotherapy or targeted therapy (including antibody drug therapy): ≥ 3 weeks (≥ 2&#xD;
             weeks for 5 flourouracil-based agents, folinate agents, and/or weekly paclitaxel; ≥ 2&#xD;
             weeks (or 5 half-lives, whichever is shorter) for tyrosine kinase inhibitors; ≥ 4&#xD;
             weeks for HER2-directed biologic therapies; ≥ 6 weeks for nitrosoureas or mitomycin&#xD;
             C). Immunotherapy: ≥ 4 weeks. Strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor: ≥&#xD;
             3 elimination half-lives . Any investigational agents or treatments: ≥ 4 weeks.&#xD;
&#xD;
          8. Patients without a history of acquired immunodeficiency syndrome (AIDS)-defining&#xD;
             opportunistic infections or with a history of AIDS-defining opportunistic infections&#xD;
             and have not had an opportunistic infection within the past 12 months may be enrolled&#xD;
             per the discretion of the Investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically active brain metastases, defined as untreated and symptomatic, or requiring&#xD;
             therapy with steroids or anticonvulsants to control associated symptoms. Subjects with&#xD;
             treated brain metastases that are no longer symptomatic and who require no treatment&#xD;
             with steroids may be included in the study if they have recovered from the acute toxic&#xD;
             effect of chemotherapy or radiotherapy;&#xD;
&#xD;
          2. Subjects with multiple primary malignancies within 2 years, except adequately resected&#xD;
             non-melanoma skin cancer, curatively treated in situ disease, other solid tumors&#xD;
             curatively treated, or contralateral breast cancer);&#xD;
&#xD;
          3. Cardiovascular dysfunction or clinically significant cardiac disease, including but&#xD;
             not limited to:&#xD;
&#xD;
               -  Medical history of symptomatic chronic heart failure (New York Heart Association&#xD;
                  (NYHA) classes II-IV) or serious cardiac arrhythmia requiring treatment;&#xD;
&#xD;
               -  Medical history of myocardial infarction or unstable angina within 6 months of&#xD;
                  the first treatment;&#xD;
&#xD;
               -  Corrected QT interval by Fridericia (QTcF) prolongation of &gt; 450 milliseconds&#xD;
                  (ms) in males and &gt; 470 ms in females;&#xD;
&#xD;
          4. Medical history of clinically significant lung disease (e.g., interstitial pneumonia,&#xD;
             pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis), or patients who&#xD;
             are suspected to have these diseases by imaging at screening or requirement for&#xD;
             supplemental oxygen;&#xD;
&#xD;
          5. Known hypersensitivity to either the drug substances or inactive ingredients in the&#xD;
             drug product;&#xD;
&#xD;
          6. Existing Grade ≥ 2 peripheral neuropathy;&#xD;
&#xD;
          7. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other&#xD;
             than alopecia) not yet resolved to NCI CTCAE version 5.0, Grade ≤ 1 or baseline.&#xD;
             Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the&#xD;
             Investigator;&#xD;
&#xD;
          8. Cumulative anthracycline dose &gt; 360 mg/m2 doxorubicin or equivalent;&#xD;
&#xD;
          9. Uncontrolled infection requiring i.v. of antibiotics, antivirals or antifungals;&#xD;
&#xD;
         10. Active infection with hepatitis C (e.g., detectable antibodies to hepatitis C virus&#xD;
             [HCV]) or hepatitis B (e.g., hepatitis B surface antigen [HBsAg] positive) except&#xD;
             subjects with occult or prior hepatitis B infection (defined as positive total&#xD;
             hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus&#xD;
             (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening, and these&#xD;
             subjects must be willing to undergo monthly DNA testing and appropriate antiviral&#xD;
             therapy as indicated;&#xD;
&#xD;
         11. Patients with a history or current evidence of any concomitant condition, therapy, or&#xD;
             laboratory abnormality that, in the opinion of the Investigator, might confound the&#xD;
             results of the trial, interfere with the patient's participation and compliance;&#xD;
&#xD;
         12. Women who are lactating or pregnant, as confirmed by pregnancy test within 7 days&#xD;
             before first treatment;&#xD;
&#xD;
         13. Male and female subjects who are unwilling to use adequate contraceptive methods&#xD;
             (e.g., concomitant use of a spermicidal agent, barrier contraceptive, or/and&#xD;
             intrauterine contraceptive) during the study and for at least 7 months after the last&#xD;
             dose of GQ1001.&#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>Yan Shi</last_name>
    <phone>0512-66526166</phone>
    <email>shiy@genequantum.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>M.D. Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Scientia Clinical Research Limited</name>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>1800 727 874</phone>
    </contact>
    <investigator>
      <last_name>Charlotte Lemech, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cabrini Institute in Melbourne, Australia</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of Bengbu medical college</name>
      <address>
        <city>Bengbu</city>
        <state>Anhui</state>
        <zip>233099</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Huan Zhou</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dianming Li</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Tongren Hospital Affiliated to Capital University of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100005</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Shurong Zhang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chinese PLA general hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100039</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Bo Yang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Southern Medical University Hospital in the south</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>516006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yabing Guo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen Memorial Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>528406</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jieqiong Liu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yanqiu Zhao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Hong Zong</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hubei Huazhong University of Science and provincial Cancer Hospital Affiliated Union Hospital of Tongji Medical College</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Kunyu Yang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hubei Cancer Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430079</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Dongde Wu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Shanzhi Gu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Liaoning Cancer Hospital &amp; Institute</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110801</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Zhendong Li</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shandong Tumor Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250117</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Zhehai Wang</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yuping Sun</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanghai Ninth People's Hospital affiliated with the Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Wei Guo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jia Fan</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Huichuan Sun</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Affiliated to Shanghai Jiaotong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jun Zhang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanghai East Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jin Li</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ye Guo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Changhai Hospital of Shanghai</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Xianbao Zhan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanghai Pulmonary Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Caicun Zhou</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>West China School of Medicine and West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Lei Liu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Lulu Liu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310005</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Meiyu Fang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>China</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</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 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HER2-positive</keyword>
  <keyword>Biliary Tract Cancer</keyword>
  <keyword>Salivary Gland Carcinomas</keyword>
  <keyword>Non- Small Cell Lung Cancer</keyword>
  <keyword>Advanced Solid Tumor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Biliary Tract Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04450732
org study id: GQ1001X2101
nct id: NCT04450732
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Modified 3+3 Design
primary purpose: Treatment
masking: None (Open Label)
measure: Dose Limiting Toxicities (DLTs).
time frame: End of Cycle 1 (21-day cycle)
description: Adverse events will be assessed using NCI CTCAE version 5.0 and will be evaluated by the investigator and the sponsor for the eligibility of DLT.
measure: Maximum Tolerated Dose (MTD) or Dose Recommended for Dose Expansion (DRDE)
time frame: After each cohort completes the DLT observation period (Day 1 to Day 21 after the first dose of study treatment) or has a DLT or becomes not DLT-evaluable
description: The SRC will also determine the MTD/DRDE based on the totality of data for all tested dose levels.
measure: Incidence and Severity of Adverse Events (AEs)
time frame: from baseline to 30 days after last dose
description: Safety and Tolerability of GQ1001
measure: Number of Participants with Abnormal Laboratory Values
time frame: rom baseline through Cycle 8 (each cycle is 21 days) and up to 30 days from treatment discontinuationafter last dose
description: Safety and Tolerability of GQ1001
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of GQ1001
time frame: through study completion, an average of 1 year
measure: Peak Plasma Concentration of GQ1001 (Cmax)
time frame: through study completion, an average of 1 year
measure: Time at which the Cmax is Observed (Tmax)
time frame: through study completion, an average of 1 year
measure: Half Life of GQ1001 (T1/2)
time frame: through study completion, an average of 1 year
measure: Mean Residence Time of GQ1001 (MRT)
time frame: through study completion, an average of 1 year
measure: Volume of Distribution of GQ1001 (Vd)
time frame: through study completion, an average of 1 year
measure: Preliminary Efficacy of GQ1001 Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and CT of MRI scans
time frame: through study completion, an average of 1 year
measure: Immunogenicity
time frame: through study completion, an average of 1 year
description: Anti-GQ1001 antibody/anti-therapeutic antibody
measure: Preliminary Efficacy
time frame: through study completion, an average of 1 year
description: objective response rate (ORR)
measure: Preliminary Efficacy
time frame: through study completion, an average of 1 year
description: disease control rate (DCR)
measure: Preliminary Efficacy
time frame: through study completion, an average of 1 year
description: duration of response (DoR)
measure: Preliminary Efficacy
time frame: through study completion, an average of 1 year
description: progression-free survival (PFS)
arm group label: Dose Escalation
arm group type: Experimental
description: GQ1001 will be administered intravenously every 21 days. Dose Escalation will be guided by a modified 3+3 design.
arm group label: Dose Expansion
arm group type: Experimental
description: GQ1001 at the Dose Recommended for Dose Expansion will be administered intravenously every 21 days. Dose expansion will further evaluate the MTD or DRDE in different types of malignant solid tumor in four cohorts.
intervention type: Drug
intervention name: GQ1001
description: anti-HER2 antibody drug conjugate
arm group label: Dose Escalation
arm group label: Dose Expansion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yan Shi
phone: 0512-66526166
email: shiy@genequantum.com
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
investigator: 
investigator: 
facility: 
status: Recruiting
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facility: 
status: Recruiting
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facility: 
status: Recruiting
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status: Recruiting
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facility: 
status: Recruiting
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facility: 
status: Recruiting
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facility: 
status: Recruiting
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facility: 
status: Recruiting
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facility: 
status: Recruiting
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facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: Australia
country: China
country: United States
responsible party type: Sponsor
mesh term: Biliary Tract Neoplasms