Advanced Solid Tumors
Conditions
Brief summary
The purpose of the study is to evaluate safety, pharmacokinetics,immunogenicity and efficacy of QLS31903 alone in the treatment of advanced cancer.
Interventions
DRUGQLS31903
0.01μg/kg-2.16 μg/kg QLS31903 for injection
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactYan Chen, PhD
Outcome results
None listed