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

NCT07688187 | Recruiting Phase 1 FDA Drug

• 1 other identifier: PD32766-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Clear Cell Renal Cell Carcinoma

Keywords

ccRCC; Renal Cell Carcinoma (Kidney Cancer); Renal Cell Carcinoma (RCC); CA9; Actinium; Copper; Theranostics

Outcome Measures

Primary Outcomes (4)

• Number and proportion of participants who experience at least 1 dose-limiting toxicities (DLTs).

  Number of participants with DLT and DLT rate

  Through completion of DLT evaluation (6weeks)

• Incidence, intensity, seriousness, and causality of adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse event of special interest (AESI) and serious adverse events (SAEs).

  Number and proportion of participants with AEs, TEAEs, AESI and SAEs.

  Through study completion, an average of 6 months.

• Incidence of TEAEs leading to dose delay, dose interruption, dose reduction, and/or discontinuation.

  Number and proportion of participants with TEAEs leading to dose delay, dose interruption, dose reduction, and/or discontinuation as a measure of tolerability.

  Through study completion. an average of 6 months

• Maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of PD-32766T based on dose-limiting toxicities.

  MTD and RDE are determined based on the occurrence of DLTs during the DLT evaluation period.

  Through completion of DLT evaluation (6weeks).

Secondary Outcomes (4)

• Area under the plasma concentration-time curve (AUC) of PD-32766T

  Through completion of 6 cycles (each cycle is 4 or 6 weeks)

• Maximum observed concentration (Cmax) of PD-32766T

  Through completion of 6 cycles (each cycle is 4 or 6 weeks)

• Urine PK profile of PD-32766T after IV injection

  Through completion of 6 cycles (each cycle is 4 or 6 weeks)

• Objective response rate (ORR), Disease control rate (DCR) and Duration of response (DoR) according to RECIST v1.1

  Through study completion, an average 6 months.

Study Arms (2)

Phase 1a Dose Escalation

EXPERIMENTAL

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.

Drug: PD-32766D (a Copper-64 [64Cu] labeled peptide); Drug: PD-32766T (an Actinium-225 [225Ac] labeled peptide)

Phase 1b Dose Expansion

EXPERIMENTAL

Subjects will receive PD-32766T in recommended dose levels and schedule.

Drug: PD-32766D (a Copper-64 [64Cu] labeled peptide); Drug: PD-32766T (an Actinium-225 [225Ac] labeled peptide)

Interventions

PD-32766D (a Copper-64 [64Cu] labeled peptide) DRUG

After PD-32766D IV injection, undergo a PET/CT scan.

Phase 1a Dose Escalation; Phase 1b Dose Expansion

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.

Phase 1a Dose Escalation; Phase 1b Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• PeptiDream Inc.: lead

Study Sites (1)

Research site

Omaha, Nebraska, 68130, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Clinical Lead

CONTACT

044-270-1300; PD_CA9_clinical@peptidream.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 7, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 7, 2026

Record last verified: 2026-06

Locations

US (1)