Study of PD-32766D/T for Clear Cell Renal Cell Carcinoma
This study is testing two related treatments, PD-32766D and PD-32766T, for people with clear cell renal cell carcinoma (a type of kidney cancer) that has returned or is difficult to treat. You would first receive an injection of PD-32766D and have a PET/CT scan to see if your tumor has a specific marker called Carbonic Anhydrase IX (CA9). If it does, you may then receive up to six cycles of PD-32766T, which is given intravenously (into a vein). This study aims to understand how safe PD-32766T is, how your body handles it, and if it shows any early signs of fighting the cancer. This is for adults aged 18 and older whose cancer has progressed after standard treatments.
- Study design
- This is an open-label, multi-center study with an estimated 60 participants. It is a Phase 1a/1b study, meaning it's an early-stage trial looking at safety and dosage.
- What's involved
- You would first have an IV injection of PD-32766D followed by a PET/CT scan. If eligible, you would then receive up to 6 cycles of PD-32766T intravenously, with safety monitored for about 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored through the completion of the study, which is an average of 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Theranostic Pair PD-32766D/T in Participants With Carbonic Anhydrase IX Positive Clear Cell Renal Cell Carcinoma
At a glance
Conditions
NCT07688187
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Research site
Omaha, Nebraskano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
What this trial measures
- Number and proportion of participants who experience at least 1 dose-limiting toxicities (DLTs).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).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.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.Through completion of DLT evaluation (6weeks).
MTD and RDE are determined based on the occurrence of DLTs during the DLT evaluation period.