A Study of GQ1005 in Subjects With HER2-Expressing Advanced Solid Tumors
NCT ID: NCT06154343
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
150 participants
INTERVENTIONAL
2022-11-23
2025-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
GQ1005 will be administered intravenously every 21 days. Dose Escalation will be guided by Bayesian Optimal Interval (BOIN) Design.
Multiple dose grouping
GQ1005
an antibody drug conjugate
Dose Expansion
GQ1005 at the recommended phase II dose (RP2D) will be administered intravenously every 21 days. Dose expansion will further evaluate the MTD or RP2D in different types of malignant solid tumor in four cohorts.
GQ1005
an antibody drug conjugate
Interventions
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GQ1005
an antibody drug conjugate
Eligibility Criteria
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Inclusion Criteria
2. Aged 18 years or older, both male and female.
3. The expected survival time is more than 3 months.
4. ECOG performance status Score 0 or 1.
5. LVEF ≥ 50% by ECHO or MUGA scan within 28 days prior to the first dose of study drug.
6. Histologically or cytologically confirmed malignancy with at least 1 measurable lesion as assessed by RECIST v1.1.
7. Good organ function, confirmed by the following laboratory test results at Screening and within 7 days prior to the first dose of study drug:
Platelet count ≥ 100,000/mm3; hemoglobin ≥ 9g/dL; ANC ≥ 1500/mm3; Serum CREA ≤ 1.5 × ULN, or estimated CREA clearance ≥ 60 mL/min (Cockcroft-Gault equation); ALT and AST ≤ 3 × ULN (≤ 5 x ULN if liver metastases are present); Total bilirubin ≤ 1.5 x ULN for subjects with Gilbert's syndrome or ≤ 2 x ULN for subjects with liver metastases at baseline; Prothrombin time and activated partial thromboplastin time ≤ 1.5 × ULN;
8. Adequate washout period prior to the first treatment, defined as follows:
Major surgery ≥ 4 weeks; radiotherapy ≥ 4 weeks (≥ 2 weeks if the radiotherapy is palliative stereotactic radiotherapy without abdominal involvement); seed-radioactive therapy ≥ 3 months; Nuclein therapy ≥ 3 months; autotransplantation ≥ 3 months; Hormone therapy ≥ 2 weeks or as per investigator's judgment (breast cancer subjects) Chemotherapy or targeted therapy (including antibody drug therapy) ≥ 2 weeks (5-FU-based drugs, folinic acid preparations and/or weekly paclitaxel therapy);
* 2 weeks (or 5 half-lives, whichever is longer) (tyrosine kinase inhibitor);
* 4 weeks (HER2-targeted biological therapy);
* 6 weeks (nitrosourea or mitomycin C);
* 3 weeks (any other chemotherapy/targeted therapy);
* 2 weeks (Chinese patent medicine with clear antitumor indication) antitumor immunotherapy ≥ 4 weeks; Any investigational drug or treatment ≥ 4 weeks; Strong inhibitors of cytochrome P450 enzyme 3A4 (CYP3A4) ≥ 1 week; Organic Anion Transport Polypeptide (OATP) Inhibitors ≥ 1 week;
9. Failure of standard treatment, or intolerance, or absence of standard treatment, confirmed by pathology, HER2 expression (including IHC1+, IHC2+, IHC3+ and/or ISH\*+) or subjects with advanced/unresectable or metastatic solid tumors with HER2 exon 19 or 20 mutations (non-small cell lung cancer only). If only ISH\*, NGS reports are available, contact the Medical Monitor.
10. Failure of standard treatment, intolerance, or absence of standard treatment, confirmed by pathology, HER2 overexpression (IHC 3+ or IHC 2+ and ISH\* +) Advanced/unresectable or metastatic breast cancer.
11. Advanced breast cancer with low HER2 expression, unresectable, or metastatic breast cancer that has failed standard treatment, or is not tolerated, or has no standard treatment, is confirmed by pathology. (IHC 2+ and ISH\*- or ISH unknown, or IHC 1+).
12. Non-small cell lung cancer with a HER2 exon 19 or 20 mutation that has failed, or is not tolerated, or is confirmed by a documented pathology without standard treatment.
13. Advanced/unresectable or metastatic solid tumors with HER2 expression that have failed standard therapy, are not tolerated, or are without standard therapy, and are confirmed by pathology, with HER2 overexpression preferred. (IHC 3+ or IHC 2+ or ISH\* +) Adenocarcinoma of gastric and gastroesophageal junction; Other preferred tumor types include HER2 overexpression. (IHC 3+ or IHC 2+ or ISH\* +) Urothelial cancer, biliary tract cancer, endometrial cancer; Breast cancer and non-small cell lung cancer are excluded.
* ISH+: FISH or two-color in situ hybridization (DISH).
Exclusion Criteria
2. Cardiovascular dysfunction or clinically significant cardiac conditions, including but not limited to:
* Symptomatic CHF (New York Heart Association classes II to IV) or severe cardiac arrhythmia requiring treatment
* History of myocardial infarction or troponin levels consistent with myocardial infarction (defined by the American College of Cardiology guidelines) within 6 months prior to the first dose, and unstable angina pectoris within 6 months prior to the first dose of study drug;
* QTcF prolongation at Screening \>460 milliseconds (ms) (male) and \>470 ms (female) except for right bundle branch block.
3. Clinically significant acute and chronic lung disease. (e.g., interstitial pneumonia, pulmonary infection, pulmonary fibrosis, and severe radiation pneumonitis), or subjects with suspected pulmonary disease based on imaging at screening, or subjects requiring oxygen.
4. People with known hypersensitivity to recombinant humanized anti-HER2 monoclonal antibody-DXd conjugate drugs and their components or to humanized monoclonal antibody products.
5. Poorly controlled pleural, ascites, or pericardial effusions.
6. Toxicity that has not resolved from prior antineoplastic therapy, defined as toxicity (other than alopecia) that has not resolved to ≤ Grade 1 or baseline levels, is at the discretion of the investigator for the eligibility of subjects with chronic Grade 2 toxicities.
7. The prior anthracycline exposure dose met the following criteria: adriamycin \> 500mg/m2; Epirubicin \>900mg/m2; Pirarubicin \> 950mg/m2; Mitoxanthraquinone \>120mg/m2; other (i.e. liposomal doxorubicin or other anthracycline \>equivalent to 500 mg/m2 of doxorubicin); If more than one anthracycline is used, the cumulative dose must not exceed the equivalent of 500 mg/m2 of doxorubicin.
8. There is an active infection requiring treatment with intravenous antibiotics, antivirals, or antifungals.
9. Known HIV infection.
10. Active hepatitis C virus infection. (HCV antibody positive and HCV-RNA higher than the upper limit of reference value); Active hepatitis B virus infection. (HBsAg positive and/or HBcAb positive and HBV-DNA quantitation ≥2000 IU/ml);, to be eligible for enrollment, subjects with chronic hepatitis B will have to agree to monthly DNA testing and receive appropriate antiviral therapy as indicated.
11. Live vaccine was administered within 30 days prior to the first dose of study drug.
12. Previous or current evidence of any concomitant disease, treatment, or laboratory abnormality that the investigator believes may confound the results of the trial or interfere with subject participation and compliance.
13. He has received treatment with an antibody-conjugated drug comprising a topoisomerase I inhibitor ezotecan derivative.
14. Breastfeeding women or women with confirmed pregnancy by a pregnancy test within 7 days prior to the first treatment.
15. Reluctant to contraception during the study and for at least 7 months after the last dose of study drug.
16. Subjects with multiple primary malignancies within the past 3 years, with the exception of fully resected non-melanoma skin cancer, cured disease in situ, cured contralateral breast cancer.
18 Years
ALL
No
Sponsors
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GeneQuantum Healthcare (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Chinese PLA general hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Haerbin Medical University
Haerbin, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
Shengjing hospital of China medical universty
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Fudan university Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an University
Xi'an, Shangxi, China
Suining Central Hospital
Suining, Sichuan, China
Sichuan Cancer Hospital
Chengdu, Sichuang, China
Tianjin medical university cancer institute & hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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The FAHOZ University
Role: primary
Other Identifiers
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GQ1005-102
Identifier Type: -
Identifier Source: org_study_id