Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer - Trial NCT05613894
Access comprehensive clinical trial information for NCT05613894 through Pure Global AI's free database. This Phase 1 trial is sponsored by University of Utah and is currently Not yet recruiting. The study focuses on Metastatic Castration-resistant Prostate Cancer. Target enrollment is 33 participants.
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Study Focus
Sponsor & Location
University of Utah
Timeline & Enrollment
Phase 1
May 01, 2023
May 01, 2028
Primary Outcome
The rate of dose-limiting toxicities (DLTs) during the DLT evaluation period,The proportion of patients without progression as defined by PCWG3-modified RECIST 1.1 at 24 weeks.
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).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05613894
Non-Device Trial