Trials / Not Yet Recruiting
Not Yet RecruitingNCT07453394
QLS5132 Combination Therapy in Advanced Solid Tumors
A Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenous QLS5132 Combination Therapy in Participants With Advanced Solid Tumors
- Status
- Not Yet Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 626 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Gastric Cancer (GC)
- Non-small Cell Lung Cancer (NSCLC)
- Endometrial Cancer
- Advanced Solid Tumors
- Ovarian Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QLS5132; Bevacizumab | Intravenous infusion，Q3W |
| DRUG | QLS5132; Platinum; Bevacizumab | Intravenous infusion，Q3W |
| DRUG | QLS5132; Olaparib; Bevacizumab | Olaparib is oral; all others are intravenous infusion，Q3W |
| DRUG | QLS5132; QL1706; QL2107 | Intravenous infusion，Q3W |
| DRUG | QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin | Intravenous infusion，Q3W |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2027-04-01
- Completion
- 2029-02-01
- First posted
- 2026-03-06
- Last updated
- 2026-03-06
Source: ClinicalTrials.gov record NCT07453394. Inclusion in this directory is not an endorsement.