Clinical Trial · NCT07623460

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

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Amber Ryba (CONTACT)

aryba@hoosiercancer.org

317-634-5842

Stuthi Perimbeti, MD, MPH (PRINCIPAL_INVESTIGATOR)

Stuthi Perimbeti, MD, MPH (CONTACT)

sperimbeti@pennstatehealth.psu.edu

717-531-4800

ClinicalTrials.gov

NCT07623460

Drug / Compound

PSMA-617

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

Age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-2.
1. 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.
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.
Metastatic Castrate Resistant Prostate Cancer (mCRPC) with histologically/cytologically confirmed adenocarcinoma without small cell histology.

Exclusion

1. 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.
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. NOTE: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of registration. Base of skull lesions without definitive evidence of dural or brail parenchymal involvement are 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. NOTE: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial as approved by the Principal Investigator.
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.