QLS5132 Combination Therapy in Advanced Solid Tumors

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Endometrial Cancer; Non-small Cell Lung Cancer (NSCLC); Gastric Cancer (GC); Advanced Solid Tumors; Ovarian Cancer

Treatments: Drug: QLS5132; QL1706; QL2107; Drug: QLS5132; Olaparib; Bevacizumab; Drug: QLS5132; Platinum; Bevacizumab; Drug: QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin; Drug: QLS5132; Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07453394

QLS5132-201

Details and patient eligibility

About

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.

Enrollment: 626 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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626 participants in 5 patient groups

QLS5132 combined wtih bevacizumab

Experimental group

Description:

QLS5132 in combination with bevacizumab

Treatment:

Drug: QLS5132; Bevacizumab

QLS5132 combined wtih platinum

Experimental group

Description:

QLS5132 in combination with platinum, followed by sequential QLS5132 alone or in combination with bevacizumab

Treatment:

Drug: QLS5132; Platinum; Bevacizumab

QLS5132 combined wtih Olaparib

Experimental group

Description:

QLS5132 in combination with Olaparib, followed by sequential QLS5132 alone or in combination with bevacizumab

Treatment:

Drug: QLS5132; Olaparib; Bevacizumab

QLS5132 combined wtih immune checkpoint inhibitors

Experimental group

Description:

QLS5132 in combination with immune checkpoint inhibitors

Treatment:

Drug: QLS5132; QL1706; QL2107

QLS5132 combined with immune checkpoint inhibitors and chemotherapy

Experimental group

Description:

QLS5132 in combination with immune checkpoint inhibitors and chemotherapy

Treatment:

Drug: QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin