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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
PeptiDream Inc.
Study ID
NCT07688187
Phase
PHASE1
Status
Recruiting
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Conditions

  • Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PD-32766D (a Copper-64 [64Cu] labeled peptide) — DRUG
    After PD-32766D IV injection, undergo a PET/CT scan.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a Dose Escalation
    PD-32766D is administered for imaging and then, subjects with positive tumor uptake will receive PD-32766T in recommended dose levels and schedule according Safety Review Committee.
  • Experimental: Phase 1b Dose Expansion
    Subjects will receive PD-32766T in recommended dose levels and schedule.

Primary Outcome Measure

Number and proportion of participants who experience at least 1 dose-limiting toxicities (DLTs). [ Time Frame: Through completion of DLT evaluation (6weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Research siteOmahaNebraska68130
Site Contact

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Research site· Omaha, NE

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