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

Nuvation Bio

Status and phase: Withdrawn; Phase 2; Phase 1

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

Treatments: Drug: NUV-422; Drug: Enzalutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05191017

NUV-422-04

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Phase 1b Dose Escalation

Experimental group

Description:

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.

Treatment:

Drug: Enzalutamide

Drug: NUV-422

Phase 2

Experimental group

Description:

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.

Treatment:

Drug: Enzalutamide

Drug: NUV-422