A Study of Theranostic Pair PD-32766D/T in Participants With Carbonic Anhydrase IX Positive Clear Cell Renal Cell Carcinoma
Sponsor: PeptiDream Inc. • ClinicalTrials.gov ID: NCT07688187
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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.
Interventions
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PD-32766D (a Copper-64 [64Cu] labeled peptide)
(Drug)
After PD-32766D IV injection, undergo a PET/CT scan.
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PD-32766T (an Actinium-225 [225Ac] labeled peptide)
(Drug)
The PD-32766T of the specified dose per cycle is administered intravenously for up to 6 cycles.
Eligibility criteria
Conditions
Locations
- Research site — Omaha, Nebraska, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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