FDA IND Approval: Phase 1/2 Trial of CLDN18.2 ADC LCB02A

FDA IND approval for Phase 1/2 trial of CLDN18.2-targeted ADC LCB02A (May 14, 2026)
Up to 191 patients, ~60 months duration (estimated completion May 14, 2031)
Target indications: CLDN18.2-positive advanced solid tumors (including gastric/GEJ and pancreatic cancers)
Phase 1 dose escalation, Phase 2 dose expansion (Simon's 2-stage design)
Primary endpoints: Phase 1 DLT and safety, Phase 2 ORR
Risk disclosure: ~10% probability of final approval; trial may be modified based on results

Filing: Major Management Matters Related to Investment Decision (Decision on Clinical Trial Plan Approval Application, etc.) (Approval of U.S. IND for Phase 1/2 Clinical Trial of CLDN18.2 Antibody-Drug Conjugate (ADC) LCB02A)
Company: LigaChem Biosciences (141080)
Submission: LigaChem Biosciences Inc.
Receipt: 05-14-2026
Under KRX KOSDAQ Market Division