Actively Recruiting
Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer
Led by University of Utah · Updated on 2025-10-31
33
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- Confirmed prostate adenocarcinoma without small cell histology
- Prior orchiectomy and/or ongoing androgen-deprivation therapy with castrate serum testosterone levels
- Previous treatment with at least one Novel Hormone Therapy such as abiraterone, enzalutamide, apalutamide, or darolutamide
- Eligible for 177Lu-PSMA-617 therapy with at least one PSMA-positive lesion
- Progressive metastatic castration-resistant prostate cancer
- ECOG Performance Status of 0 or 1
- Adequate organ function including blood counts, liver and kidney tests within specified limits
- Agree to use medically accepted contraception during and for 6 months after the study
- Recovery to baseline or Grade 1 or less from prior treatment toxicities
- Able to provide informed consent
- Life expectancy greater than 3 months
You will not qualify if you...
- Receiving other investigational anti-cancer agents
- Prior treatment with cabozantinib
- Previous treatment with certain radiotherapies within 6 months
- Previous PSMA-targeted radioligand therapy
- Recent use of kinase inhibitors, cytotoxic, biologic, or systemic anticancer therapy within specified washout periods
- Recent radiation therapy within specified washout periods
- Ongoing complications from prior radiation therapy
- Symptomatic or impending spinal cord compression
- Known or unstable brain metastases
- Incomplete wound healing from recent surgery
- Other active malignancies requiring treatment within 3 years except certain low-risk cancers
- Use of certain anticoagulants not allowed in the study
- Uncontrolled cardiovascular or gastrointestinal disorders
- Significant bleeding or pulmonary lesions within recent weeks
- Serious non-healing wounds or fractures
- Moderate to severe liver impairment
- Known untreated or active infections including HIV and hepatitis
- Medical or psychiatric conditions affecting compliance
- Use of prohibited medications without adequate washout period
- Inability to swallow tablets
- QTc interval greater than 500 ms on ECG within 28 days before treatment start
AI-Screening
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Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
S
Susan Sharry
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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