Clinical Trial

Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer

Study acronym: CaboLu
Recruiting Phase 1
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Summary
This is an open-label, phase 1b dose-escalation study of cabozantinib in combination with 177Lu-PSMA-617 in subjects with mCRPC. The primary hypothesis is that cabozantinib with 177Lu-PSMA will be safe and have efficacy in patients with mCRPC. The dose-escalation phase (Part 1) will assess the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period and identify the MTD and/or recommended dose and schedule for the subsequent expansion phase (Part 2).
Protocol Amendment History 1 change
critical Recruitment resumed after suspension 2026-08-13
Trial Details
NCT Number NCT05613894
Lead Sponsor University of Utah
Collaborators: Exelixis
Conditions Metastatic Castration-resistant Prostate Cancer
Enrollment 33 participants
Start Date 2023-07-14
Primary Completion 2026-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-12