Leads Biolabs' PD-L1/4-1BB Bispecific Antibody IND Application for Combination Therapy in Metastatic Colorectal Cancer Approved, Strengthening GI Oncology Franchise

NMPA’s Center for Drug Evaluation (CDE) has approved the IND application for an open-label, multicenter Phase Ib/II clinical trial of Leads Biolabs’ PD-L1/4-1BB bispecific antibody Opamtistomig (LBL-024) in combination therapy for metastatic colorectal cancer (mCRC).

The study aims to evaluate the safety and efficacy of Opamtistomig combination regimens in mCRC patients and to explore potential predictive biomarkers.

Opamtistomig is the first 4‑1BB–targeting bispecific antibody globally to reach a single‑arm pivotal trial stage and is being developed for multiple solid tumor indications, including biliary tract cancer, gastric cancer, ESCC, NSCLC, SCLC, and now mCRC.

Leads Biolabs highlights that this IND approval extends its gastrointestinal oncology footprint from biliary tract, gastric, and esophageal cancers into colorectal cancer, an area of high unmet need.

Opamtistomig (LBL‑024) is an Fc‑muted bispecific antibody that simultaneously blocks PD‑L1‑mediated immunosuppression and conditionally activates 4‑1BB, thereby enhancing antitumor immune responses with a favorable safety profile in earlier clinical trials.