Actively Recruiting
A Study of GQ1010 in Subjects With Advanced Solid Tumors
Led by GeneQuantum Healthcare (Suzhou) Co., Ltd. · Updated on 2025-02-10
260
Participants Needed
5
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, phase I/II study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of GQ1010 and preliminary anti-tumor efficacy in advanced malignant solid tumor subjects
CONDITIONS
Official Title
A Study of GQ1010 in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 years old or older
- Able to provide written informed consent and willing to comply with study procedures
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed advanced or metastatic solid malignant tumors with epithelial origin that have relapsed or progressed after standard treatments, or no standard treatment available
- Agreed to provide archived or fresh tumor tissue samples
- Measurable tumor lesion based on RECIST version 1.1
- Confirmed disease progression during or after most recent treatment or assessed as unlikely to benefit from previous treatment
- ECOG performance status of 0 or 1
- Agree to use reliable contraceptive measures if of reproductive potential during and for 7 months after study drug
- Adequate bone marrow reserve and organ function with specified laboratory values
- Adequate treatment washout period before initial treatment
- Specific documented tumor types with prior standard therapies or no standard therapy available as detailed in criteria 12 to 21
You will not qualify if you...
- Pregnant or breastfeeding
- Significant concurrent diseases including heart failure (NYHA Grade II-IV), recent myocardial infarction, unstable angina, stroke within 6 months, thromboembolic events within 6 months, severe aortic stenosis, uncontrolled arrhythmia, congenital long QT syndrome, prolonged QT interval, uncontrolled hypertension or diabetes
- Active infections requiring systemic treatment
- Poorly controlled pleural, pericardial effusion or ascites requiring frequent drainage
- Active brain metastases or leptomeningeal carcinomatosis requiring steroids or anticonvulsants; brain stem metastasis or spinal cord compression
- Other primary malignancies within last 3 years except certain treated cancers
- Interstitial lung disease or severe pulmonary impairment requiring oxygen
- Severe pulmonary compromise from pulmonary illnesses or autoimmune disorders with lung involvement
- Active or history of inflammatory bowel disease or recent severe gastrointestinal conditions
- Tumor surrounding important blood vessels with high bleeding risk
- Active hepatitis B, hepatitis C, tuberculosis, syphilis, or HIV infection
- Grade 2 or higher corneal disease with symptoms
- Prior Trop-2 targeted therapy or ADC therapy with topoisomerase I inhibitors (except specified cohorts)
- Unresolved toxicities from prior cancer therapy above grade 1 or baseline
- History of severe hypersensitivity to GQ1010 or other monoclonal antibodies
- Other diseases or lab abnormalities increasing safety risk or interfering with study
- Positive SARS-CoV-2 test within 30 days before first study drug dose
- Received live vaccine within 30 days before first study drug dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute
Beijing, China
Actively Recruiting
2
Department of Medical Oncology, Harbin Medical University Cancer Hospital
Harbin, China
Actively Recruiting
3
Tianjin medical university cancer institute & hospital
Tianjin, China
Actively Recruiting
4
Hubei Cancer Hospital
Wuhan, China
Actively Recruiting
5
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
Research Team
Y
Yan Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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