drugset / Trial / NCT05613894

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

NCT05613894

Phase 1 Suspended 33 enrolled University of Utah Exelixis · collab
Non-randomizedSequentialOpen-labelTreatment

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).

Timeline

Start
2023-07-14
Primary completion
2026-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabozantinib Small molecule Oral
Background 177Lu-PSMA-617 Other / unclassified

Indications