Drug intelligence / Profile preview

QLS31905 + oxaliplatin + capecitabine

Development stage
Phase 3
Lead developer
Qilu Pharmaceutical
Modality
T-cell Engagers → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral
01

Overview

QLS31905 + oxaliplatin + capecitabine is an investigational combination therapy for advanced solid tumors, particularly targeting Claudin18.2-positive gastrointestinal cancers. QLS31905 is a bispecific antibody designed to engage Claudin18.2 on tumor cells and CD3 on T cells, redirecting T cells for tumor cell lysis. Oxaliplatin is a platinum-based chemotherapeutic agent that forms DNA crosslinks, inhibiting DNA synthesis and transcription, and capecitabine is a prodrug of 5-FU (fluorouracil) that disrupts DNA synthesis by inhibiting thymidylate synthase. This combination is under evaluation in early-phase clinical trials (Phase 2) for its efficacy and safety in patients with advanced GI cancers. QLS31905 is administered via intravenous infusion, while oxaliplatin is given intravenously and capecitabine is administered orally. The therapy is developed by Qilu Pharmaceutical and is not yet approved for marketing. Preclinical and phase 1 results suggest tolerable safety and preliminary antitumor activity in Claudin18.2-positive patients.

02

Targets

CD3 (T-cell surface glycoprotein CD3)Claudin 18.2DNATS (Thymidylate synthase)

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