Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC
Prostate Cancer, Prostatic Cancer, Cancer of Prostate
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Phase 1, Phase 2, metastatic castration-resistant prostate cancer, NUV-422, enzalutamide, Xtandi, CDK, CDK inhibition, CDK2/4/6
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Gabrail Cancer Center Research
- Pennsylvania Cancer Specialists and Research Institute
- NEXT Virginia
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase 1b Dose Escalation
Phase 2
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.
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.