A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLS31903 in Advanced Solid Tumor Patients

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: QLS31903

• Registration Number: NCT05823285
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

The purpose of the study is to evaluate safety, pharmacokinetics,immunogenicity and efficacy of QLS31903 alone in the treatment of advanced cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-22
• Study First Submitted: 2023-03-23
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-20
• Last Update Submitted: 2023-04-20
• Study First Posted: 2023-04-21
• Last Update Posted: 2023-04-21
• Primary Completion: 2025-06-15
• Study Completion: 2027-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QLS31903	QLS31903	0.01μg/kg-2.16 μg/kg QLS31903 for injection

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fudan Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China