QLS5132 Combination Therapy in Advanced Solid Tumors

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT07453394
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and effectiveness of the investigational drug QLS5132 (injectable) in combination with other therapies for participants with advanced solid tumors. This is a multicenter, open-label study consisting of two parts: dose escalation and tumor-specific expansion. The main questions it aims to answer are: * In the dose-escalation part: What is the safety, tolerability, PK profile, and preliminary efficacy of QLS5132 combination therapy, and what are the recommended dose(s) for expansion? * In the expansion part: What is the anti-tumor efficacy and further safety profile of QLS5132 combination therapy at the selected dose(s) in participants with specific tumor types? Participants will: * Be enrolled in sequential cohorts to receive QLS5132 in combination with other anticancer agents. * Undergo regular assessments for safety, drug concentration levels (PK), and tumor response.

Key Dates

Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Feb 28, 2029

Study Design

Enrollment
626 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QLS5132 combined wtih bevacizumab
    QLS5132 in combination with bevacizumab
  • Experimental: QLS5132 combined wtih platinum
    QLS5132 in combination with platinum, followed by sequential QLS5132 alone or in combination with bevacizumab
  • Experimental: QLS5132 combined wtih Olaparib
    QLS5132 in combination with Olaparib, followed by sequential QLS5132 alone or in combination with bevacizumab
  • Experimental: QLS5132 combined wtih immune checkpoint inhibitors
    QLS5132 in combination with immune checkpoint inhibitors
  • Experimental: QLS5132 combined with immune checkpoint inhibitors and chemotherapy
    QLS5132 in combination with immune checkpoint inhibitors and chemotherapy

Primary Outcome Measure

Incidence and severity of adverse events [ Time Frame: up to 2 years ]

Central Contacts

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