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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. Identifier: NCT04450732
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : March 22, 2023
Information provided by (Responsible Party):
GeneQuantum Healthcare (Suzhou) Co., Ltd.

Brief Summary:
Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors

Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer HER2-positive Biliary Tract Cancer HER2-Positive Salivary Gland Carcinomas HER2-Positive Advanced Solid Tumor Drug: GQ1001 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Modified 3+3 Design
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 7, 2020
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dose Escalation
GQ1001 will be administered intravenously every 21 days. Dose Escalation will be guided by a modified 3+3 design.
Drug: GQ1001
anti-HER2 antibody drug conjugate

Experimental: Dose Expansion
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.
Drug: GQ1001
anti-HER2 antibody drug conjugate

Primary Outcome Measures :
  1. 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.

  2. 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 ]
    The SRC will also determine the MTD/DRDE based on the totality of data for all tested dose levels.

Secondary Outcome Measures :
  1. Incidence and Severity of Adverse Events (AEs) [ Time Frame: from baseline to 30 days after last dose ]
    Safety and Tolerability of GQ1001

  2. 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 ]
    Safety and Tolerability of GQ1001

  3. Area Under the Plasma Concentration Versus Time Curve (AUC) of GQ1001 [ Time Frame: through study completion, an average of 1 year ]
  4. Peak Plasma Concentration of GQ1001 (Cmax) [ Time Frame: through study completion, an average of 1 year ]
  5. Time at which the Cmax is Observed (Tmax) [ Time Frame: through study completion, an average of 1 year ]
  6. Half Life of GQ1001 (T1/2) [ Time Frame: through study completion, an average of 1 year ]
  7. Mean Residence Time of GQ1001 (MRT) [ Time Frame: through study completion, an average of 1 year ]
  8. Volume of Distribution of GQ1001 (Vd) [ Time Frame: through study completion, an average of 1 year ]
  9. 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 ]
  10. Immunogenicity [ Time Frame: through study completion, an average of 1 year ]
    Anti-GQ1001 antibody/anti-therapeutic antibody

  11. Preliminary Efficacy [ Time Frame: through study completion, an average of 1 year ]
    objective response rate (ORR)

  12. Preliminary Efficacy [ Time Frame: through study completion, an average of 1 year ]
    disease control rate (DCR)

  13. Preliminary Efficacy [ Time Frame: through study completion, an average of 1 year ]
    duration of response (DoR)

  14. Preliminary Efficacy [ Time Frame: through study completion, an average of 1 year ]
    progression-free survival (PFS)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Signed informed consent form and able to comply with the protocol;
  2. Male and female subjects ≥18 years of age;
  3. ECOG PS of 0 or 1, the estimated life expectancy ≥ 3 months;
  4. LVEF ≥ 50% as determined by echocardiography (ECHO);
  5. Patients must have pathologically documented advanced/unresectable or metastatic solid tumor with HER2-positive (as defined below) that is relapsed or refractory to standard therapy or for which there is no standard therapy and progressed. Patients must have a least one measurable disease lesion. Tumor specimens to identify HER2 status should be obtained within the past 6 months.

    Definition of HER2-positive

    • Advanced/unresectable or metastatic breast cancer: immunohistochemistry (IHC) 3+, or IHC 2+ and in situ hybridization positive (ISH+)*;
    • Advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: IHC 3+, or IHC 2+ and ISH+*;
    • Other HER2-positive advanced/unresectable or metastatic solid malignant tumor: determined by IHC, ISH, Next Generation Sequencing, or other analysis techniques as appropriate;

      • ISH: fluorescence in situ hybridization (FISH) or dual in situ hybridization (DISH); ISH positivity is defined as a ratio of ≥ 2.0 for the number of HER2 gene copies to the number of signals for CEP17. ISH assay is not required when IHC result is 3+. ISH assay should be performed to confirm HER2 positivity when IHC result is 2+.
  6. Adequate organ function confirmed at screening and within 7 days before the first treatment, as evidenced by:

    Platelet count: ≥ 100,000/mm3 ; Hemoglobin : ≥ 9 g/dL; Absolute neutrophil count (ANC): ≥ 1500/mm3 ; Serum creatinine: ≤ 1.5 × ULN (upper limit of normal), or creatinine clearance ≥ 60 mL/min (using Cockcroft Gault formula) ; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) : ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present); Total bilirubin : ≤ 1.5 × ULN (except for patients with Gilbert's Syndrome); Prothrombin time and activated partial thromboplastin time: ≤ 1.5 × ULN.

  7. Adequate washout period before the first treatment as defined by:

    Major surgery: ≥ 4 weeks. Radiation therapy: ≥ 4 weeks (≥ 2 weeks for palliative stereotactic radiation therapy without abdominal). Autologous transplantation: ≥ 3 months.

    Hormonal therapy: ≥ 2 weeks or per Investigator's discretion for breast cancer patients.

    Chemotherapy or targeted therapy (including antibody drug therapy): ≥ 3 weeks (≥ 2 weeks for 5 flourouracil-based agents, folinate agents, and/or weekly paclitaxel; ≥ 2 weeks (or 5 half-lives, whichever is shorter) for tyrosine kinase inhibitors; ≥ 4 weeks for HER2-directed biologic therapies; ≥ 6 weeks for nitrosoureas or mitomycin C). Immunotherapy: ≥ 4 weeks. Strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor: ≥ 3 elimination half-lives . Any investigational agents or treatments: ≥ 4 weeks.

  8. Patients without a history of acquired immunodeficiency syndrome (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 chemotherapy or radiotherapy;
  2. Subjects with multiple primary malignancies within 2 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, other solid tumors curatively treated, or contralateral breast cancer);
  3. Cardiovascular dysfunction or clinically significant cardiac disease, including but not limited to:

    • Medical history of symptomatic chronic heart failure (New York Heart Association (NYHA) classes II-IV) or serious cardiac arrhythmia requiring treatment;
    • Medical history of myocardial infarction or unstable angina within 6 months of the first treatment;
    • Corrected QT interval by Fridericia (QTcF) prolongation of > 450 milliseconds (ms) in males and > 470 ms in females;
  4. Medical history of clinically significant lung disease (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis), 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. Existing Grade ≥ 2 peripheral neuropathy;
  7. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI CTCAE version 5.0, Grade ≤ 1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator;
  8. Cumulative anthracycline dose > 360 mg/m2 doxorubicin or equivalent;
  9. Uncontrolled infection requiring i.v. of antibiotics, antivirals or antifungals;
  10. Active infection with hepatitis C (e.g., detectable antibodies to hepatitis C virus [HCV]) or hepatitis B (e.g., hepatitis B surface antigen [HBsAg] positive) except subjects with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening, and these subjects must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated;
  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 (e.g., concomitant use of a spermicidal agent, barrier contraceptive, or/and intrauterine contraceptive) during the study and for at least 7 months after the last dose of GQ1001.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04450732

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Contact: Yan Shi 0512-66526166

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Sponsors and Collaborators
GeneQuantum Healthcare (Suzhou) Co., Ltd.
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Responsible Party: GeneQuantum Healthcare (Suzhou) Co., Ltd. Identifier: NCT04450732    
Other Study ID Numbers: GQ1001X2101
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: March 22, 2023
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GeneQuantum Healthcare (Suzhou) Co., Ltd.:
Biliary Tract Cancer
Salivary Gland Carcinomas
Non- Small Cell Lung Cancer
Advanced Solid Tumor
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases