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NCT Number: NCT05823285

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

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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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fudan Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

Zhenggang Ren, PhD

CONTACT

[email protected]

8613681971302

Zhenggang Ren, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QLS31903

Drug

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

Primary outcomes

  1. Maximum tolerated dose（MTD）for Phase 1a

    Time frame: 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.

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

    Time frame: Duration of study, approximately 24 months

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

  3. 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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Chen, PhD

CONTACT

[email protected]

8617843558626

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Apr 21, 2023
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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