Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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. |
Drug: NUV-422
NUV-422 is an investigational drug for oral dosing.
Drug: Enzalutamide
Enzalutamide
Other Names:
|
Experimental: 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. |
Drug: NUV-422
NUV-422 is an investigational drug for oral dosing.
Drug: Enzalutamide
Enzalutamide
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with enzalutamide to determine the recommended Phase 2 combination dose (RP2cD) [During the DLT period (28 days)]
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and laboratory abnormalities
- Phase 2 Dose Expansion: Prostate-specific antigen (PSA)-response rate (PSA-RR) [Every 4 weeks throughout study treatment, an average of 6 months]
PSA per standard criteria
- Phase 2 Dose Expansion: Objective response rate (ORR) [Every 8 weeks throughout study treatment, an average of 6 months]
ORR per standard criteria
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone
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Have radiographic or biochemical evidence of progression as determined by Investigator per standard criteria
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Have no known active or symptomatic central nervous system (CNS) disease
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Prior therapy with abiraterone required and:
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For Phase 1b only: up to 2 prior taxane-based chemotherapy regimens allowed for castration-resistant disease
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For Phase 2 only: Patients must not have received prior taxane-based chemotherapy for castrate-resistant disease or prior treatment with CDK inhibitors
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Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
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Adequate bone marrow and organ function
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Eligible to receive enzalutamide
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Life expectancy of > 6 months
Exclusion Criteria:
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History of seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma)
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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
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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
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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
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Prior therapy with enzalutamide, apalutamide, darolutamide, or investigational androgen receptor inhibitors
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Known allergy or hypersensitivity to enzalutamide
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Nuvation Bio Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NUV-422-04