Zanzalintinib Efficacy Post Pluvicto® in Chemotherapy Naïve Metastatic Castration Resistant Prost… (NCT07623460) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Zanzalintinib Efficacy Post Pluvicto® in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer
30 participantsStarted 2026-09
Plain-language summary
This is a multi-center single arm phase II study of zanzalintinib after Pluvicto in chemotherapy-naïve mCRPC. Subjects will receive zanzalintinib 60mg orally (PO) once daily. Zanzalintinib may continue until evidence of radiographic progression, intolerable adverse events, or withdrawal of consent. Two interim analyses will be performed; a safety interim analysis to be performed for the first 5 evaluable subjects, and a futility interim analysis to be performed for the first 15 evaluable subjects.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
. Age ≥ 18 years at the time of consent.
. ECOG Performance Status of 0-2.
. Metastatic Castrate Resistant Prostate Cancer (mCRPC) with histologically/cytologically confirmed adenocarcinoma without small cell histology.
. Prior cancer treatment must be completed at least 14 days prior to registration NOTE: Antiandrogen agent, against LHRH axis, such as Leuprolide or institutional equivalent, Relugolix, Degarelix etc. are to be continued during the course of the treatment.
. Must have recovered from adverse effects of any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy). CTCAE adverse events ≤ grade 1 are acceptable. CTCAE adverse events grade 2 or greater may be acceptable as determined by the treating Investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients must have had at least one dose of prior Pluvicto therapy for prostate adenocarcinoma. Patients must have received PARP inhibitor if the tumor has BRCA 1 or 2 pathogenic mutations prior to enrolling on this study unless intolerant or contraindicated per treating investigator.
. Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 14 days prior to registration.
Exclusion criteria
. Receipt of chemotherapy in the mCRPC disease state. NOTE: Prior exposure and any number of lines of chemo (including docetaxel) during hormone naïve or castrate sensitive state of the cancer is allowed.
. Any other active malignancy or diagnosis of another malignancy within 2 years before first dose of study treatment requiring systemic treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.
. Known central nervous system (CNS) metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 28 days before the first dose of study treatment.
. Treatment with any investigational drug within 14 days prior to registration.
. History of severe allergic anaphylactic reactions or hypersensitivity to zanzalintinib or any of their excipients such as Cabozantinib.
. Prior treatment with Zanzalintinib.
. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before first dose of study treatment.
. Receipt of any type of cytotoxic, biologic (such as systemic Immune Checkpoint Inhibitors) or other systemic anticancer therapy (including investigational) within 28 days before the first dose of study treatment. NOTE: The antiandrogen abiraterone is permitted up to 7 days prior to the first dose of study treatment. Concomitant use of megestrol acetate or leuprolide/Relugolix/ Degarelix/ Equivalent drugs such as Eligard etc. per institutional guidelines is permitted. Other types of hormonal therapies with similar use require prior approval from the sponsor-investigator.