Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC

NCT ID: NCT05191017

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2026-07-31

Brief Summary

NUV-422-04 is an open-label Phase 1b/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with enzalutamide. The study population is comprised of adults with mCRPC. Patients will self-administer NUV-422 and 160 mg enzalutamide orally in 28-day cycles. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.

Conditions

Prostate Cancer; Prostatic Cancer; Cancer of Prostate; Cancer of the Prostate; Prostate Neoplasm; Castrate Resistant Prostate Cancer; Castration Resistant Prostatic Cancer; Castration Resistant Prostatic Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1b Dose Escalation

NUV-422 will be administered orally at escalating dose levels in combination with enzalutamide until the recommended Phase 2 combination dose (RP2cD) is determined.

160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422.

Group Type: EXPERIMENTAL

NUV-422

Intervention Type: DRUG

NUV-422 is an investigational drug for oral dosing.

Enzalutamide

Intervention Type: DRUG

Enzalutamide

Phase 2

NUV-422 will be administered orally at the RP2cD in combination with enzalutamide.

160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422.

Group Type: EXPERIMENTAL

NUV-422

Intervention Type: DRUG

NUV-422 is an investigational drug for oral dosing.

Enzalutamide

Intervention Type: DRUG

Enzalutamide

Interventions

NUV-422

NUV-422 is an investigational drug for oral dosing.

Intervention Type: DRUG

Enzalutamide

Enzalutamide

Intervention Type: DRUG

Other Intervention Names

Xtandi

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone

2. Have radiographic or biochemical evidence of progression as determined by Investigator per standard criteria

3. Have no known active or symptomatic central nervous system (CNS) disease

4. Prior therapy with abiraterone required and:

• For Phase 1b only: up to 2 prior taxane-based chemotherapy regimens allowed for castration-resistant disease
• For Phase 2 only: Patients must not have received prior taxane-based chemotherapy for castrate-resistant disease or prior treatment with CDK inhibitors

5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2

6. Adequate bone marrow and organ function

7. Eligible to receive enzalutamide

8. Life expectancy of > 6 months

Exclusion Criteria

1. History of seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma)

2. Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs) radiation, or biological anti-cancer therapy within 14 days prior to first dose of NUV-422 and enzalutamide

3. Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (or < 5 half-lives) for myelosuppressive agent prior to the first dose of NUV-422 and enzalutamide

4. Requires medications that are known to be strong inducers and /or inhibitors of CYP3A4/5 enzymes, except enzalutamide

• For Phase 1b only: Requires medications that are known to be moderate inducers and /or inhibitors of CYP3A4/5 enzymes, except enzalutamide

5. Prior therapy with enzalutamide, apalutamide, darolutamide, or investigational androgen receptor inhibitors

6. Known allergy or hypersensitivity to enzalutamide

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nuvation Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gabrail Cancer Center Research

Canton, Ohio, United States

Pennsylvania Cancer Specialists and Research Institute

Gettysburg, Pennsylvania, United States

NEXT Virginia

Fairfax, Virginia, United States

Countries

United States

Other Identifiers

NUV-422-04

Identifier Type: -

Identifier Source: org_study_id