Status:
UNKNOWN
A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
Eligibility Criteria
Inclusion
- Subjects voluntarily participate in the study and sign the informed consent form;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Expected survival time ≥ 3 months;
- Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors;
- No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease;
- Tumor tissue samples determined to have moderate-to-high Claudin18.2 expression by immunohistochemistry (IHC);
- At least one measurable lesion per RECIST v1.1;
- Patients with adequate cardiac, liver, renal function, etc.
Exclusion
- History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
- Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
- Known central nervous system metastases;
- Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test;
- Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse;
- Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT06041035
Start Date
October 1 2023
End Date
October 1 2025
Last Update
September 18 2023
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142