Clinical trial · Interventional
Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5132 Monotherapy in Subjects With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 ATD + BOIN, given IV every 3 weeks. Up to 12 subjects may be enrolled in promising dose levels. * Phase 1b: Evaluates QLS5132's anti-tumor efficacy in specific CLDN6-positive solid tumors, including ovarian cancer, NSCLC, gastric cancer, and others. Expansion studies at 1\~3 selected dose levels follow successful Phase 1a results.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QLS5132 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Finding and Expansion- QLS5132 Monotherapy
- description
- Intravenous infusion，Q3W
- interventionNames
- Drug: QLS5132
Primary outcomes (3)
- measure
- Incidence and severity of adverse events and serious adverse events
- timeFrame
- up to 2 years
- description
- Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- 28days
- description
- Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available