An Open-Label, Multicenter, Phase 1a/1b, Dose Escalation/Dose Expansion Clinical Trial of Theranostic Pair PD-32766D, a 64Cu-Labeled Peptide and PD-32766T, an 225Ac-Labeled Peptide Targeting Carbonic Anhydrase IX in Adult Participants With Relapsed or Refractory Clear Cell Renal Cell Carcinoma Who Have Progressed From or Could Not be Administered Due to Medical Unsuitability or Limited Access to All Standard of Care Therapies

Summary

This is an open-label, multicenter, Phase 1a/1b study evaluating the theranostic pair 64Cu-PD-32766 Injection (PD-32766D) and 225Ac-PD-32766 Injection (PD-32766T) in adult patients with relapsed or refractory Carbonic Anhydrase IX (CA9)-expressing clear cell renal cell carcinoma (ccRCC). The primary objective is to evaluate the safety and tolerability of PD-32766T, and to characterize its pharmacokinetics and preliminary antitumor activity. Participants will first undergo imaging with PD-32766D to assess CA9 expression. Subjects with positive tumor uptake will be eligible to receive PD-32766T. In Phase 1a, PD-32766T will be administered in an escalating dose levels and schedule determined according to protocol and Safety Review Committee recommendations. In Phase 1b, participants will receive PD-32766T at the recommended dose and schedule identified from Phase 1a to further evaluate safety, tolerability, and preliminary efficacy. A total of up to 60 participants will be enrolled in the study.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No