Status:
NOT_YET_RECRUITING
Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The Phase 1 trial includes Phase 1a (dose-escalation) and Phase 1b (dose-expansion): * Phase 1a: Assesses safety, tolerability, PK, and preliminary efficacy of QLS5132 in advanced solid tumors using ...
Eligibility Criteria
Inclusion
- Advanced solid tumors;
- Measurable disease, per RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Adequate organ function;
- Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to NCI-CTCAE v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral;
Exclusion
- Previous treatment with drugs targeting CLDN6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
- 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;
- Progressive or symptomatic brain metastases;
- Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;
- History of significant cardiac disease, or poorly controlled diabetes mellitus;
- History of recurrent autoimmune diseases;
- History of myelodysplastic syndrome (MDS) or AML;
- History of other active malignant tumors within 3 years before signing the informed consent form;
- If female, is pregnant or breastfeeding;
- Be allergic to any component of QLS5132 or its excipients.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT06932094
Start Date
May 1 2025
End Date
February 1 2028
Last Update
April 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zhejiang Cancer Hospital
Hangzhou, China