Advanced Solid Tumors, Endometrial Cancer, Gastric Cancer (GC), Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer
Conditions
Keywords
CLDN6 ADC
Brief 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.
Interventions
DRUGQLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin
Intravenous infusion，Q3W
DRUGQLS5132; Bevacizumab
Intravenous infusion，Q3W
DRUGQLS5132; Platinum; Bevacizumab
Intravenous infusion，Q3W
DRUGQLS5132; Olaparib; Bevacizumab
Olaparib is oral; all others are intravenous infusion，Q3W
DRUGQLS5132; QL1706; QL2107
Intravenous infusion，Q3W
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events | up to 2 years | Incidence and severity of adverse events |
| Maximum tolerated dose (MTD) | From basline to Day 28 | Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants |
| Recommended Phase 2 Dose (RP2D) | up to 2 years | — |
Contacts
CONTACTTao Zhu, PhD
Outcome results
None listed