Crescent Receives FDA IND Clearance for PD-L1-Targeted ADC CR-002
Published in Drugs development & discovery.
Published October 5, 2026. Source date: October 5, 2026.
Crescent Biopharma announced FDA clearance of its Investigational New Drug application for CR-002, an antibody-drug conjugate targeting PD-L1 and carrying a topoisomerase inhibitor payload. The candidate is being developed for advanced solid tumors.
The company plans to start its global Phase 1/2 APOLLO trial in the fourth quarter of 2026. Dose-escalation and tumor-specific backfill cohorts are expected to include approximately 200 participants, with additional enrollment possible in expansion cohorts. Initial safety, pharmacokinetic and preliminary antitumor-activity data are expected in the second half of 2027.
CR-002 uses an antibody and cleavable linker intended to deliver its payload into target cells. Planned tumor groups include lung, head and neck, gastrointestinal and gynecological cancers. IND clearance allows investigational clinical development; it does not establish efficacy or authorize commercial treatment. Trial timing and future results remain uncertain.