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

NCT05823285 | Recruiting Phase 1

• 1 other identifier: QLS31903-101
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose（MTD）for Phase 1a

  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.

  21days or 14 days after the first target dose(whichever is longer）

• Recommended phase 2 dose(RP2D) for Phase 1a

  The RP2D is defined as the dose level chosen by Safety Monitoring Committee(SMC)

  Duration of study, approximately 24 months

• Objective Response Rate (ORR) for phase 1b

  ORR is the percentage of patients with best response of CR and PR

  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

Study Arms (1)

QLS31903

EXPERIMENTAL

0.01μg/kg-2.16 μg/kg QLS31903 for injection

Drug: QLS31903

Interventions

QLS31903 DRUG

0.01μg/kg-2.16 μg/kg QLS31903 for injection

QLS31903

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Study Officials

• Xiaoyan Kang, PhD

  Qilu Pharmaceutical Co., Ltd.

  STUDY CHAIR

Central Study Contacts

Yan Chen, PhD

CONTACT

8617843558626; yan12.chen@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 21, 2023
• Study Start: March 22, 2023
• Primary Completion: June 15, 2025
• Study Completion (Estimated): June 15, 2027
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)