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

NCT05191017 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: NUV-422-04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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

Keywords

Phase 1; Phase 2; metastatic castration-resistant prostate cancer; NUV-422; enzalutamide; Xtandi; CDK; CDK inhibition; CDK2/4/6

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• Phase 2 Dose Expansion: Objective response rate (ORR)

  ORR per standard criteria

  Every 8 weeks throughout study treatment, an average of 6 months

Study Arms (2)

Phase 1b Dose Escalation

EXPERIMENTAL

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.

Drug: NUV-422; Drug: Enzalutamide

Phase 2

EXPERIMENTAL

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.

Drug: NUV-422; Drug: Enzalutamide

Interventions

NUV-422 DRUG

NUV-422 is an investigational drug for oral dosing.

Phase 1b Dose Escalation; Phase 2

Enzalutamide DRUG

Enzalutamide

Also known as: Xtandi

Phase 1b Dose Escalation; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone
• Have radiographic or biochemical evidence of progression as determined by Investigator per standard criteria
• Have no known active or symptomatic central nervous system (CNS) disease
• 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
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
• Adequate bone marrow and organ function
• Eligible to receive enzalutamide
• Life expectancy of \> 6 months

You may not qualify if:

• History of seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma)
• 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
• 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
• 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
• Prior therapy with enzalutamide, apalutamide, darolutamide, or investigational androgen receptor inhibitors
• Known allergy or hypersensitivity to enzalutamide

Sponsors & Collaborators

• Nuvation Bio Inc.: lead

Study Sites (3)

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Pennsylvania Cancer Specialists and Research Institute

Gettysburg, Pennsylvania, 17325, United States

Location

NEXT Virginia

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 13, 2022
• Study Start: September 1, 2022
• Primary Completion: January 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

US (3)