QLS5132 Combination Therapy in Advanced Solid Tumors

NCT07453394
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Phase
Phase 1/Phase 2
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Recruitment status
Not yet recruiting
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Participants
626
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Lead sponsor
Qilu Pharmaceutical Co., Ltd.
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Start date
2026-04-01
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Summary
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.
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Short title
QLS5132 Combination Therapy in Advanced Solid Tumors
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Official title
A Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenous QLS5132 Combination Therapy in Participants With Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2029-02-01
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First posted
2026-03-06
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Registry last updated
2026-03-06
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Primary completion date
2027-04-01
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Start date
2026-04-01
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Participants
626
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Participant count basis
Estimated
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Planned participants
626
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Protocol amendments
0
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Registry sponsor category
Industry
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Lead sponsor
Qilu Pharmaceutical Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07453394
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ClinicalTrials.gov ID
NCT07453394
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Incidence and severity of adverse events

    Timeframe: up to 2 years

    Incidence and severity of adverse events

  2. Maximum tolerated dose (MTD)

    Timeframe: From basline to Day 28

    Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants

  3. Recommended Phase 2 Dose (RP2D)

    Timeframe: up to 2 years

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  1. Advanced solid tumors;
  2. Measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1);
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  4. Adequate organ function;
  5. Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral.

  1. Previous treatment with drugs targeting CLDN6 (including antibody-drug conjugates [ADCs]), or any drug containing topoisomerase I inhibitors (including ADCs);
  2. Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 2 weeks with small molecule and within 4 weeks with biologic before the first dose of QLS5132;
  3. Progressive or symptomatic brain metastases;
  4. Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;
  5. History of significant cardiac disease, or poorly controlled diabetes mellitus;
  6. History of recurrent autoimmune diseases;
  7. History of myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia (AML);
  8. History of a second primary malignancy;
  9. If female, is pregnant or breastfeeding;
  10. Be allergic to any component of QLS5132 or its excipients.
Sources for eligibility
clinicaltrials.gov

Related records

Drugs (6)

Lead sponsors (1)

Conditions (6)

Targets (4)