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

Prostate Cancer Clinical Trial

Official title:

Phase 1b/2 Safety and Efficacy Study of NUV-422 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05191017
• Other study ID #: NUV-422-04
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: September 2022
• Est. completion date: July 2026

Study information

• Verified date: August 2022
• Source: Nuvation Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Prostate
• Cancer of the Prostate
• Castrate Resistant Prostate Cancer
• Castration Resistant Prostatic Cancer
• Castration Resistant Prostatic Neoplasms
• Neoplasms
• Prostate Cancer
• Prostate Neoplasm
• Prostatic Cancer
• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

Intervention

Drug:
• NUV-422
NUV-422 is an investigational drug for oral dosing.
• Enzalutamide
Enzalutamide

Locations

Country	Name	City	State
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	NEXT Virginia	Fairfax	Virginia
United States	Pennsylvania Cancer Specialists and Research Institute	Gettysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Nuvation Bio Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with enzalutamide to determine the recommended Phase 2 combination dose (RP2cD)	Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and laboratory abnormalities	During the DLT period (28 days)
Primary	Phase 2 Dose Expansion: Prostate-specific antigen (PSA)-response rate (PSA-RR)	PSA per standard criteria	Every 4 weeks throughout study treatment, an average of 6 months
Primary	Phase 2 Dose Expansion: Objective response rate (ORR)	ORR per standard criteria	Every 8 weeks throughout study treatment, an average of 6 months