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

Recruiting now · Phase 1

Conditions studied: Clear Cell Renal Cell Carcinoma

In brief

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 facts

Study ID

NCT07688187

Run by

PeptiDream Inc.

People needed

60

Starts

2026-06-01

Expected to finish

2029-06-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants aged ≥18 years.
• Participants with confirmed diagnosis of ccRCC will be included based on the following characteristics:
• Histological confirmed locally advanced, unresectable, or metastatic ccRCC, after all available standard therapy.
• Presence of evaluable disease by Response Evaluation Criteria In Solid Tumors (RECIST) guideline (defined by RECIST v1.1).
• Presence of positive tumor uptake
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
• The participant's with adequate organ function
• Life expectancy of at least 12 weeks as assessed by the Investigator.

You may not qualify if…

• Concurrent serious (as determined by the Investigator), uncontrolled medical conditions, or life-threatening or other significant comorbid conditions.
• Any chemotherapy, radiotherapy, immunotherapy, major surgery, biologic, investigational or hormonal therapy for treatment of solid tumors within 28 days.
• Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy.
• Administration of a radiopharmaceutical with therapeutic intent within a period of 6 months.
• Any previous CA9 targeting treatment.
• Known hypersensitivity to the active substance or to any of the excipients of the PD-32766D and or T.
• Clinically unstable CNS tumor at the time of screening.
• History of bowel perforation or bowel infarction, history of active stomach or duodenum ulcer or fistula in the last 2 years, history of gastroesophageal reflux disease or enterocolitis Grade ≥3 according to NCI-CTCAE and/or known active gastrointestinal infection, any unresolved prior radiation-induced gastrointestinal injury.
• Acute infection requiring IV antibiotics, antivirals, or antifungals within 14 days prior to the initiation of treatment (oral treatment are allowed).
• Pregnant or breastfeeding women.
• Known active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
• Have been diagnosed with another primary malignancy.
• Have significant, uncontrolled, or active cardiovascular disease
• Bladder outflow obstruction or unmanageable urinary incontinence.
• Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
• Any major surgery within 12 weeks before enrolment.
• History of psychiatric illness or social situations likely to interfere with ability to comply with protocol required assessment or give informed consent.

Where it is running

• Research site — Omaha, Nebraska, United States (enrolling)

Full record on ClinicalTrials.gov

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