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New treatment option for Clear Cell Renal Cell Carcinoma
Official title A Study of Theranostic Pair PD-32766D/T in Participants With Carbonic Anhydrase IX Positive Clear Cell Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT07688187
What this study is testing
What is PD-32766D (a Copper-64 [64Cu] labeled peptide)?
PD-32766D (a Copper-64 [64Cu] labeled peptide) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for clear cell renal cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- 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.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Omaha, Nebraska, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Omaha, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.