MedTrace Logo

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

NCT05613894 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-10-31

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Cabozantinib

(177Lu)-PSMA-617 will be administered every 6 weeks for up to 6 cycles per SOC. Oral Cabozantinib taken daily at home.

Sponsors & Collaborators

Principal Investigators

  • Umang Swami, MD · Huntsman Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2026-05-01
Completion
2028-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05613894 on ClinicalTrials.gov