Theranostic pair labeled PD-32766D/T in CA9-positive clear cell kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter Phase 1a/1b trial evaluating a copper-64 labeled diagnostic peptide (PD-32766D) and an actinium-225 labeled therapeutic peptide (PD-32766T) in adults with relapsed or refractory CA9-expressing clear cell RCC. Participants undergo initial imaging with PD-32766D to confirm CA9-positive tumors; those with positive uptake may receive PD-32766T. The study uses dose-escalation in Phase 1a to establish safety and pharmacokinetics, followed by a single recommended-dose Phase 1b expansion to further assess safety and preliminary efficacy. Up to 60 participants may be enrolled across phases at participating sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female participants aged ≥18 years.
2. 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).
3. Presence of positive tumor uptake
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
5. The participant's with adequate organ function
6. Life expectancy of at least 12 weeks as assessed by the Investigator.

Exclusion Criteria:

1. Concurrent serious (as determined by the Investigator), uncontrolled medical conditions, or life-threatening or other significant comorbid conditions.
2. Any chemotherapy, radiotherapy, immunotherapy, major surgery, biologic, investigational or hormonal therapy for treatment of solid tumors within 28 days.
3. Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy.
4. Administration of a radiopharmaceutical with therapeutic intent within a period of 6 months.
5. Any previous CA9 targeting treatment.
6. Known hypersensitivity to the active substance or to any of the excipients of the PD-32766D and or T.
7. Clinically unstable CNS tumor at the time of screening.
8. 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.
9. Acute infection requiring IV antibiotics, antivirals, or antifungals within 14 days prior to the initiation of treatment (oral treatment are allowed).
10. Pregnant or breastfeeding women.
11. Known active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
12. Have been diagnosed with another primary malignancy.
13. Have significant, uncontrolled, or active cardiovascular disease
14. Bladder outflow obstruction or unmanageable urinary incontinence.
15. Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
16. Any major surgery within 12 weeks before enrolment.
17. History of psychiatric illness or social situations likely to interfere with ability to comply with protocol required assessment or give informed consent.

Where it's running

• Research site
  Omaha, Nebraska, United States Recruiting

Study contacts

• Study coordinator: Clinical Lead
• Email: PD_CA9_clinical@peptidream.com
• Phone: 044-270-1300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.