Evaluation of PD-32766D and PD-32766T in Adults with Relapsed or Refractory CA9-Positive Clear Cell Renal Cell Carcinoma

What this Trial Is About

Researchers are evaluating a theranostic pair of drugs, 64Cu-PD-32766 Injection PD-32766D and 225Ac-PD-32766 Injection PD-32766T, in adults with relapsed or refractory Carbonic Anhydrase IX CA9-expressing clear cell renal cell carcinoma ccRCC. This open-label, multicenter Phase 1a1b study aims to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PD-32766T in this patient group. Participants first receive an injection of PD-32766D followed by a PETCT scan to check for CA9 expression in their tumors. Those with positive tumor uptake become eligible to receive PD-32766T. In Phase 1a, PD-32766T is given intravenously in escalating doses and schedules based on the protocol and Safety Review Committee guidance. In Phase 1b, participants receive PD-32766T at the recommended dose and schedule identified from Phase 1a to further evaluate its safety and preliminary efficacy, with up to 6 intravenous cycles planned. During the study, participants are closely monitored for dose-limiting toxicities, adverse events, and treatment effects over an average of 6 months. Assessments include pharmacokinetic sampling, imaging, and tumor response evaluations using RECIST v1.1 criteria. The study tracks safety outcomes such as adverse event severity and any dose adjustments. Participants overall health, organ function, and quality of life are evaluated to understand the treatment impact throughout the trial period.

A Study of Theranostic Pair PD-32766D/T in Participants With Carbonic Anhydrase IX Positive Clear Cell Renal Cell Carcinoma