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Recruiting NCT05823285

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

Phase I Interventional Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QLS31903.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

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

Primary outcome measures

  • Maximum tolerated dose（MTD）for Phase 1a [Time frame: 21days or 14 days after the first target dose(whichever is longer）]
  • Recommended phase 2 dose(RP2D) for Phase 1a [Time frame: Duration of study, approximately 24 months]
  • Objective Response Rate (ORR) for phase 1b [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan Zhongshan Hospital — Shanghai

Identifiers

NCT: NCT05823285 · QLS31903-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗