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QLS31905 + QL2107 + XELOX in CLDN18.2+ Gastric/GEJ Adenocarcinoma
NCT06942767Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Jun 2025
- Primary completion
- Dec 2026
- Sponsor
- Qilu Pharmaceutical
- Modality
- Bispecific Antibodies, Monoclonal Antibodies
- Drugs
- QLS-31905
- Conditions
- gastric adenocarcinomagastroesophageal junction adenocarcinoma
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Overview
Phase 2, open-label, single-arm trial of QLS-31905 in gastric adenocarcinoma and gastroesophageal junction adenocarcinoma, sponsored by Qilu Pharmaceutical. Primary endpoints: Dose Limiting Toxicity at 42 days, Maximum Tolerated Dose at 42 days and 1 more. Planned start Jun 2025; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
QLS31905+QL2107+ XELOX
QLS31905 combined with QL2107, Oxaliplatin, and Capecitabine
03
Who it enrols
Patients with CLDN18.2-positive unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma who have not received prior systemic treatment for advanced disease.
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Endpoints
Primary
Dose Limiting Toxicity
Maximum Tolerated Dose
Objective Response Rate
Secondary
Adverse Events
Anti-Drug Antibody
Duration of Response
Progression Free Survival
Overall Survival
Maximum Concentration
Terminal Elimination Half-Life
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