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Clinical trial

A Phase 1 Study to Investigate the Safety, Tolerability，Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS31903 Injection in Subjects With Advanced Solid Tumors

ID
Name
QLS31903-101
Description
The purpose of the study is to evaluate safety, pharmacokinetics,immunogenicity and efficacy of QLS31903 alone in the treatment of advanced cancer.
Trial arms
Trial start
2023-03-22
Estimated PCD
2025-06-15
Trial end
2027-06-15
Status
Recruiting
Phase
Early phase I
Treatment
QLS31903
0.01μg/kg-2.16 μg/kg QLS31903 for injection
Arms:
QLS31903
Size
150
Primary endpoint
Maximum tolerated dose（MTD）for Phase 1a
21days or 14 days after the first target dose(whichever is longer）
Recommended phase 2 dose(RP2D) for Phase 1a
Duration of study, approximately 24 months
Objective Response Rate (ORR) for phase 1b
From fist administration of QLS31903 to disease progression，death，loss to follow up,withdrawal of consent,initiation of a new anticancer therapy,study completion/closure,whichever came first, assessed up to 24 months
Eligibility criteria
Key Inclusion Criteria: * 18 years or older, 40kg or heavier * Histologically or cytologically confirmed diagnosis of advanced solid tumor （For phase 1b, patients must have solid tumor with GPC3+ ) * Standard treatment failed or standard treatment intolerant, no standard treatment * Adequate hepatic, hematologic, and renal function Key Exclusion Criteria: * Anti-tumor treatment within 4 weeks prior to the first QLS31903 administration,except a few specific conditions * Other clinical trial within 4 weeks prior to the first QLS31903 administration * Receipt of a live or live attenuated vaccine within 30 days prior to the first QLS31903 administration * Prior treatment targeted on GPC3 * HBsAg/HBcAb positive and HBV-DNA\>10,000 copy/mL;HCV-Ab positive and HCV-RNA\>1,000 copy/mL * CNS metastasis (except asymptomatic brain metastases or symptomatic brain metastases after treatment stable for more than 4 weeks) and/or carcinomatous meningitis or leptomeningeal disease
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-04-21

1 organization

1 product

1 indication

Organization
Qilu Pharmaceutical
Product
QLS31903
Indication
Cancer