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

ConditionmCRPC (Metastatic Castration-resistant Prostate Cancer)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorStuthi Perimbeti

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Zanzalintinib

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: ZanzalintinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Radiographic progression free survival (rPFS)

rPFS is defined as the duration of time from Cycle 1 Day 1 to the date of radiographic progression per Prostate Cancer Working Group 3 (PCWG3) criteria or death due to any cause, whichever occurs first.

Time frame
3 years

Secondary outcomes

1

PSA Response

PSA response defined as a ≥50% decline in PSA from baseline (measured twice at least 3 weeks apart) using PCWG3 criteria.

Time frame
3 years
2

Objective response rate

ORR will be defined as the proportion of CR+PR using PCWG3 criteria for subjects with measurable disease

Time frame
3 years
3

Adverse events

Adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time frame
3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stuthi Perimbeti

Lead sponsor

Hoosier Cancer Research Network

Sponsor institution

Exelixis

Collaborator

Penn State Cancer Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: