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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823285
• Other study ID #: QLS31903-101
• Status: Recruiting
• Phase: Phase 1
• Start date: March 22, 2023
• Est. completion date: June 15, 2027

Study information

• Verified date: April 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Yan Chen, PhD
• Phone: 8617843558626
• Email: yan12.chen[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 15, 2027
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• QLS31903
0.01µg/kg-2.16 µg/kg QLS31903 for injection

Locations

Country	Name	City	State
China	Fudan Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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