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Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04450732
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
GeneQuantum Healthcare (Suzhou) Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 23, 2020
First Posted Date  ICMJE June 29, 2020
Last Update Posted Date October 19, 2021
Actual Study Start Date  ICMJE July 7, 2020
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2020)
Maximum Tolerated Dose (MTD) and/or Dose Limiting Toxicities (DLTs). [ Time Frame: End of Cycle 1 (21-day cycle) ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2020)
  • Incidence and Severity of Adverse Events (AEs) [ Time Frame: Cycle 1 through Cycle 8 (each cycle is 21 days) and up to 30 days from treatment discontinuation ]
    Safety and Tolerability of GQ1001
  • Number of Participants with Abnormal Laboratory Values [ Time Frame: Cycle 1 through Cycle 8 (each cycle is 21 days) and up to 30 days from treatment discontinuation ]
    Safety and Tolerability of GQ1001
  • Area Under the Plasma Concentration Versus Time Curve (AUC) of GQ1001 [ Time Frame: Cycle 1 through Cycle 8 (each cycle is 21 days) ]
  • Peak Plasma Concentration of GQ1001 (Cmax) [ Time Frame: Cycle 1 through Cycle 8 (each cycle is 21 days) ]
  • Time at which the Cmax is Observed (Tmax) [ Time Frame: Cycle 1 through Cycle 8 (each cycle is 21 days) ]
  • Half Life of GQ1001 (T1/2) [ Time Frame: Cycle 1 through Cycle 8 (each cycle is 21 days) ]
  • Mean Residence Time of GQ1001 (MRT) [ Time Frame: Cycle 1 through Cycle 8 (each cycle is 21 days) ]
  • Volume of Distribution of GQ1001 (Vd) [ Time Frame: Cycle 1 through Cycle 8 (each cycle is 21 days) ]
  • 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 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors
Official Title  ICMJE 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
Brief Summary Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Modified 3+3 Design
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HER2-positive Breast Cancer
  • HER2-positive Gastric Cancer
  • Advanced Solid Tumor
Intervention  ICMJE Drug: GQ1001
anti-HER2 antibody drug conjugate
Study Arms  ICMJE
  • Experimental: Dose Escalation
    GQ1001 will be administered intravenously every 21 days. Dose Escalation will be guided by a modified 3+3 design.
    Intervention: Drug: GQ1001
  • Experimental: Dose Expansion
    GQ1001 at the Dose Recommended for Dose Expansion will be administered intravenously every 21 days.
    Intervention: Drug: GQ1001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 25, 2020)
27
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed informed consent form and able to comply with the protocol;
  2. Male or female 18 years of age and older;
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening;
  4. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography (ECHO);
  5. Patients must have pathologically documented advanced/unresectable or metastatic solid tumor with HER2 overexpression/expression that is refractory to standard therapy or for which there is no standard available therapy;
  6. Has adequate organ function within 7 days before the first treatment;
  7. Has adequate treatment washout period before the first treatment;:
  8. Patients without a history of AIDS-defining opportunistic infections or with a history of AIDS-defining opportunistic infections and have not had an opportunistic infection within the past 12 months may be enrolled per the discretion of the Investigator.

Exclusion Criteria:

  1. Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy;
  2. Any hematologic malignancies, including leukemia (any form), lymphoma, and multiple myeloma;
  3. Cardiovascular dysfunction or clinically significant cardiac disease;
  4. Medical history of clinically significant lung disease or patients who are suspected to have these diseases by imaging at screening or requirement for supplemental oxygen;
  5. Known hypersensitivity to either the drug substances or inactive ingredients in the drug product;
  6. Grade ≥ 2 peripheral neuropathy;
  7. Unresolved toxicities from previous anticancer therapy;
  8. Cumulative anthracycline dose > 360 mg/m^2 doxorubicin or equivalent;
  9. Uncontrolled infection requiring i.v. of antibiotics, antivirals or antifungals;
  10. Active infection of hepatitis B or hepatitis C;
  11. Patients with a history or current evidence of any concomitant condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's participation and compliance;
  12. Women who are lactating or pregnant, as confirmed by pregnancy test within 7 days before first treatment;
  13. Male and female subjects who are unwilling to use adequate contraceptive methods during the study and for at least 7 months after the last dose of GQ1001;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ke Chen +8613306139991 chenk@genequantum.com
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04450732
Other Study ID Numbers  ICMJE GQ1001X2101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GeneQuantum Healthcare (Suzhou) Co., Ltd.
Study Sponsor  ICMJE GeneQuantum Healthcare (Suzhou) Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account GeneQuantum Healthcare (Suzhou) Co., Ltd.
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP