China's NMPA has approved an IND for a Phase Ib/II trial combining Leads Biolabs' PD-L1/4-1BB bispecific antibody opamtistomig with standard regimens in metastatic colorectal cancer, extending the drug's reach into one of oncology's most immunotherapy-resistant tumor types.
China's Center for Drug Evaluation (CDE), part of the National Medical Products Administration (NMPA), has approved an investigational new drug (IND) application for an open-label, multicenter phase Ib/II trial evaluating Nanjing Leads Biolabs' opamtistomig (LBL-024) in combination regimens for metastatic colorectal cancer (mCRC).¹ The trial will assess safety and efficacy while exploring predictive biomarkers for response.¹ The approval extends opamtistomig's immuno-oncology footprint from biliary tract cancer, gastric cancer, and esophageal squamous cell carcinoma into colorectal cancer, an indication the company describes as an area of high unmet clinical need.¹
“Through the synergistic dual targeting of PD-L1 and 4-1BB, opamtistomig has the potential to restore anti-tumor immune activity in cold tumors, a differentiated mechanism that has already shown encouraging preliminary signals in earlier clinical studies.”
—Dr. Charles Cai, chief medical officer of Leads Biolabs
Opamtistomig is a
The majority of metastatic colorectal cancer, roughly 95% of cases, is microsatellite stable (MSS) or mismatch repair-proficient (pMMR), and these tumors are intrinsically resistant to checkpoint inhibitor monotherapy.² Low tumor mutational burden, minimal T-cell infiltration, and an immunosuppressive tumor microenvironment are among the mechanisms cited for this resistance.² According to 2022 data from the International Agency for Research on Cancer cited in the release, colorectal cancer accounted for approximately 1.926 million new cases and 904,000 deaths globally that year, making it one of the most common gastrointestinal malignancies worldwide.¹
Dr. Charles Cai, chief medical officer of Leads Biolabs, said, "MSS/pMMR mCRC is widely recognized as an immunologically 'cold' tumor, and patients continue to face significant unmet medical needs with limited effective treatment options. Through the synergistic dual targeting of PD-L1 and 4-1BB, opamtistomig has the potential to restore anti-tumor immune activity in cold tumors, a differentiated mechanism that has already shown encouraging preliminary signals in earlier clinical studies. We are excited to further explore this novel combination strategy in the ongoing phase Ib/II study and hope to bring a more effective immunotherapy option to patients with metastatic colorectal cancer."¹ Leads Biolabs describes opamtistomig as the first 4-1BB-targeting bispecific antibody globally to advance into a single-arm pivotal trial as monotherapy, with the drug now under evaluation across 13 solid tumor indications in China.¹
The phase Ib/II mCRC study will proceed as an open-label, multicenter trial evaluating opamtistomig combination regimens, with predictive biomarker work built into the design.¹ The company has not yet disclosed a timeline for first patient dosing in this specific indication.
