Not Yet RecruitingPhase 2

Zanzalintinib in Men With Aggressive Variant Prostate Cancer

30 participantsStarted 2026-05

Plain-language summary

This is a multi-center single arm phase II study to evaluate the antitumor activity of zanzalintinib 60mg orally (PO) once daily in subjects with AVPC. Zanzalintinib may continue until radiographic progression (or beyond), intolerable adverse events, or withdrawal of consent. As long as the subject is clinically stable, subjects may receive study treatment even after radiographic progression, until they are no longer clinically benefiting from the study treatment in the opinion of the treating Investigator, or they need subsequent systemic anticancer treatment or other urgent tumor directed medical intervention to prevent life-threatening complications. This study will use a 2-stage group-sequential design for enrollment. The first stage will consist of enrolling 15 subjects. No more than 5 of the first 15 subjects can have received chemotherapy in the castrate- resistant setting.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
✓. Age ≥ 18 years at the time of consent.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 within 14 days prior to registration.
✓. Histological or cytologically proven prostate cancer
✓. Must have had evidence of metastatic disease (AJCC v.8 M1 disease) based on conventional CT/MRI and/or bone scan. This will be defined as:
✓. Bilateral orchiectomy or ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist/antagonist (surgical or medical castration), with serum testosterone \< 50 ng/ dL (\< 1.73 nmol/L) at screening.
✓. Must have progressed during or after at least one second-generation androgen receptor pathway inhibitor (abiraterone acetate, enzalutamide, apalutamide, darolutamide) given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 castrate- resistant prostate cancer (CRPC), or metastatic CRPC.
✓. Presence of at least one of the following:

Exclusion criteria

What they're measuring

Radiographic progression free survival (rPFS)

Timeframe: 6 months

Radiographic progression free survival (rPFS)

Timeframe: 6 months

Trial details

NCT IDNCT07218666

SponsorDeepak Kilari

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Deepak Kilari, MD

414-805-3666 dkilari@mcw.edu

View on ClinicalTrials.gov More Aggressive Variant Prostate Carcinoma trials