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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2027-06-15

Brief Summary

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

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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QLS31903

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

Group Type EXPERIMENTAL

QLS31903

Intervention Type DRUG

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

Interventions

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QLS31903

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

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No