Phanes Therapeutics announced the initiation of the dose expansion phase in its ongoing clinical study evaluating spevatamig in combination with chemotherapy for the treatment of biliary tract cancer (BTC). The announcement follows successful dose-limiting toxicity (DLT) clearance at two dose levels during the dose-escalation phase.
Spevatamig is a first-in-class, native IgG-like bispecific antibody that targets claudin 18.2 and CD47. Designed to enhance anti-tumor immune activity while minimizing toxicity, the candidate represents a novel therapeutic approach for gastrointestinal malignancies. The investigational agent previously received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for pancreatic cancer and Fast Track Designation in 2024 for metastatic claudin 18.2–positive pancreatic adenocarcinoma.
Phanes Therapeutics is evaluating spevatamig across multiple oncology programs, including a Phase 2 trial in combination with chemotherapy as first-line treatment for pancreatic ductal adenocarcinoma (PDAC). The company also maintains a collaboration with Merck & Co. to study the antibody in combination with pembrolizumab (Keytruda®), Merck’s anti–PD-1 therapy.
As of March 2026, more than 160 patients worldwide have received spevatamig as monotherapy or in combination regimens. The planned dose expansion in biliary tract cancer will further assess safety, tolerability, and preliminary efficacy in a broader patient population.
Phanes will present three posters on spevatamig, including preclinical and early clinical data, at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego.
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