Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol

Phase 1

• Conditions: mCRPC
• Interventions: Drug: ZEN003694; Drug: Enzalutamide

• Registration Number: NCT04145375
• Lead Sponsor: Zenith Epigenetics

Brief Summary

Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol

Detailed Description

This is an open label, non-randomized, single-arm continuation protocol study using ZEN003694. Patients who have completed participation in their original ("parent") ZEN003694 protocol and have clinical benefit as determined by the investigator may continue to receive treatment with ZEN003694 in the continuation protocol. The patient must have been enrolled in a Zenith Epigenetics sponsored ZEN003694 therapeutic study to be eligible for participation in this continuation protocol.

Study Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Study Start: 2019-11-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Protocol-defined completion in a parent ZEN003694 trial
2. Patient has clinical benefit as determined by the investigator at the time of entry to the continuation protocol
3. ECOG performance status of 0 or 1
4. Acceptable ZEN003694 tolerability, in the judgment of the investigator
5. Initiation of dosing in this continuation trial to occur within two weeks (14 days) of completing dosing in the parent trial, unless more time is approved by the sponsor in writing

Exclusion Criteria

1. Concurrent participation in another clinical investigational treatment trial
2. Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study
3. Discontinued ZEN003694 or withdrew consent to participate in original Zenith Epigenetics-sponsored ZEN003694 study
4. Any other reason that in the opinion of the Investigator would prevent the patient from completing participation or following the study schedule

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: ZEN003694 in Combination with Enzalutamide	ZEN003694	Patients who have completed participation in their original ZEN003694-002 protocol and have clinical benefit as determined by the investigator may continue to receive treatment with ZEN003694 in combination with enzalutamide
Experimental: ZEN003694 in Combination with Enzalutamide	Enzalutamide	Patients who have completed participation in their original ZEN003694-002 protocol and have clinical benefit as determined by the investigator may continue to receive treatment with ZEN003694 in combination with enzalutamide

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-related adverse events (AE) and treatment-related serious adverse events (SAE)	Up to 3 years

Secondary Outcome Measures

Name	Time	Method
Evaluate Overall survival (OS): Time from date of first dose of ZEN003694 in the parent protocol or randomization to the date of death from any cause	Up to 3 years
Evaluate radiographic response rate by RECIST 1.1 criteria	Up to 3 years

Trial Locations

Locations (2)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

University of California San Francisco Medical Center; 🇺🇸 San Francisco, California, United States