PeptiDream announces FDA clearance of IND applications for Phase 1 clinical trials of 225Ac-PD-32766 and 64Cu-PD-32766 in patients with kidney cancer

CAR-T Digest - August 2020

Weekly Digest - December 2025

22 December 2025: PeptiDream announces FDA clearance of IND applications for Phase 1 clinical trials of 225Ac-PD-32766 and 64Cu-PD-32766 in patients with kidney Cancer

PeptiDream received U.S. Food and Drug Administration IND clearance to initiate Phase 1 clinical trials of 225Ac-PD-32766 and 64Cu-PD-32766 in patients with clear cell renal cell carcinoma (ccRCC)
The Phase 1 study will evaluate safety, tolerability, and dosimetry of both agents in ccRCC, supported by preclinical and clinical data presented at major nuclear medicine and oncology conferences in 2025
PD-32766 is a CA9-targeting macrocyclic peptide radiolabeled with Actinium-225 for therapy and Copper-64 for diagnosis, forming a theranostic pair discovered using PeptiDream’s PDPS technology
Carbonic Anhydrase IX (CA9) is highly expressed in ~95% of ccRCC tumors with minimal normal tissue expression, supporting its suitability as a diagnostic and therapeutic target
A prior Phase 0 imaging study of 64Cu-PD-32766 conducted in Japan showed clear tumor accumulation and dosimetry supportive of therapeutic potential, with results presented at ASCO GU 2025