A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLS31903 in Advanced Solid Tumor Patients
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate safety, pharmacokinetics,immunogenicity and efficacy of QLS31903 alone in the treatment of advanced cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: QLS31903 0.01μg/kg-2.16 μg/kg QLS31903 for injection |
Drug: QLS31903
0.01μg/kg-2.16 μg/kg QLS31903 for injection
|
Outcome Measures
Primary Outcome Measures
- Maximum tolerated dose（MTD）for Phase 1a [21days or 14 days after the first target dose(whichever is longer）]
The MTD is determined by the number of the participants in cohort who suffer a dose-limiting toxicity (DLT). The MTD is defined as the former dose at which more than one third of the participants develop a DLT. If no DLTs are observed, the MTD is not reached.
- Recommended phase 2 dose(RP2D) for Phase 1a [Duration of study, approximately 24 months]
The RP2D is defined as the dose level chosen by Safety Monitoring Committee(SMC)
- 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]
ORR is the percentage of patients with best response of CR and PR
Eligibility Criteria
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
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Other clinical trial within 4 weeks prior to the first QLS31903 administration
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Receipt of a live or live attenuated vaccine within 30 days prior to the first QLS31903 administration
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Prior treatment targeted on GPC3
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan Zhongshan Hospital | Shanghai | Shanghai | China | 200000 |
Sponsors and Collaborators
- Qilu Pharmaceutical Co., Ltd.
Investigators
- Study Chair: Xiaoyan Kang, PhD, Qilu Pharmaceutical Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QLS31903-101