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Zanzalintinib Efficacy Post Pluvicto® in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer

NCT07623460 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-03

No results posted yet for this study

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.

Conditions

  • mCRPC (Metastatic Castration-resistant Prostate Cancer)

Interventions

DRUG

Zanzalintinib

60mg orally (PO) once daily until evidence of radiographic progression, intolerable adverse events, or withdrawal of consent.

Sponsors & Collaborators

  • Exelixis

    collaborator INDUSTRY

  • Penn State Cancer Institute

    collaborator UNKNOWN

  • Stuthi Perimbeti

    lead OTHER

Principal Investigators

  • Stuthi Perimbeti, MD, MPH · Penn State Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-09-30
Completion
2031-09-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07623460 on ClinicalTrials.gov