NCT07688187 · PeptiDream Inc.
A Study of Theranostic Pair PD-32766D/T in Participants With Carbonic Anhydrase IX Positive Clear Cell Renal Cell Carcinoma
What this study is about
This is an where both patients and doctors know the treatment given, conducted at multiple hospitals, 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).
View original scientific description
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
DRUG
PD-32766D (a Copper-64 [64Cu] labeled peptide)
After PD-32766D IV injection, undergo a PET/CT scan.
DRUG
PD-32766T (an Actinium-225 [225Ac] labeled peptide)
The PD-32766T of the specified dose per cycle is administered intravenously for up to 6 cycles.
Primary outcome measures
Number and proportion of participants who experience at least 1 dose-limiting toxicities (DLTs).
Time frame: Through completion of DLT evaluation (6weeks)
Number of participants with DLT and DLT rate
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).
Time frame: Through study completion, an average of 6 months.
Number and proportion of participants with AEs, TEAEs, AESI and SAEs.
Incidence of TEAEs leading to dose delay, dose interruption, dose reduction, and/or discontinuation.
Time frame: Through study completion. an average of 6 months
Number and proportion of participants with TEAEs leading to dose delay, dose interruption, dose reduction, and/or discontinuation as a measure of tolerability.
Maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of PD-32766T based on dose-limiting toxicities.
Time frame: Through completion of DLT evaluation (6weeks).
MTD and RDE are determined based on the occurrence of DLTs during the DLT evaluation period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Omaha, Nebraska
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations