A Study of Theranostic Pair PD-32766D/T in Participants With Carbonic Anhydrase IX Positive Clear Cell Renal Cell Carcinoma (NCT07688187)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Research site โ Omaha, Nebraska
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Research site โ Omaha, Nebraska
๐ Contact the Study Coordinator
Phone: (044) 270-1300
Email: PD_CA9_clinical@peptidream.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Clear Cell Renal Cell Carcinoma
- Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery โ Fairbanks, Alaska
- Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer โ Los Angeles, California
- Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors โ Duarte, California
- A Phase 1/2 Trial of ADI-270 in ccRCC โ Redwood City, California
- Seleno-L Methionine (SLM)-Axitinib-Pembrolizumab โ Iowa City, Iowa
- Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer โ Westwood, Kansas
Explore by condition: All Clear Cell Renal Cell Carcinoma clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.