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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT05613894
Phase
PHASE1
Status
Suspended

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

First listed
Nov 14, 2022
Start date
Jul 14, 2023
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
33 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation (Part 1)
    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
  • Experimental: Dose Expansion Cohort (Part 2)
    Expansion Phase to assess identified MTD and schedule from Part 1.

Primary Outcome Measure

The rate of dose-limiting toxicities (DLTs) during the DLT evaluation period [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute at University of UtahSalt Lake CityUtah84112-

Find similar trials in Salt Lake City, UT

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Huntsman Cancer Institute at University of Utah· Salt Lake City, UT

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