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

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).

Trial Details

NCT ID
NCT05613894
Phase
PHASE1
Sponsor
University of Utah
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Cabozantinib
Locations (sample)
  • Salt Lake City, Utah, United States|40.76078,-111.89105

Key Eligibility Criteria

  • Male subject aged ≥ 18 years.
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology.
  • Prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\<50 ng/dL or \<1.7 nmol/L).
  • Prior treatment with at least one prior Novel Hormone Therapy (NHT), defined as second-generation anti-androgen therapies that include, but are not…

For full eligibility, visit ClinicalTrials.gov.

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