Phase II Trial of Zanzalitinib in Patients With Metastatic Castration Resistant Prostate Cancer

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Pedro Barata, MD, MSc
Study ID
NCT07608718
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

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

Interventions

  • Zanzalintinib — DRUG
    60mg zanzalinitib will be given daily starting on Cycle 1 Day 1 until disease progression or unacceptable toxicity

Study Details

This research study is for people with metastatic castrate-resistant prostate cancer (mCRPC). Zanzalintinib is a new drug that shows activity in mCRPC with soft tissue or visceral metastases who have progressed on prior treatment. Participants can stay in the research for up to 24 months as long as they experience clinical benefit from it. The purpose of this study is to learn if Zanzalinitib is effective in treating metastatic castrate-resistant prostate cancer.

Key Dates

Start date
Sep 30, 2026
Status verified
May 2026
Primary completion
May 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
19 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zanzalintiniib
    Single-arm phase 2 trial of patients with mCRPC (metastatic castration-resistant prostate cancer). About 24 participants will be enrolled in the trial, 9 will initially be enrolled and if 3 participants are still alive and progression-free at 6 months, 15 more participants will be added. 1 cycle is 28 days. If a participant does not complete at least one cycle, the participant will be replaced. Participants who complete one cycle will not be replaced.

Primary Outcome Measure

Radiographic progression free survival (rPFS) at 6 months [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106
Pedro Barata, MD, MSc
[email protected]
(216)-262-1214
Pedro Barata, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center· Cleveland, OH

Related Studies