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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
NUV-422 is an investigational drug for oral dosing.
Enzalutamide
Gabrail Cancer Center Research
Canton, Ohio, United States
Pennsylvania Cancer Specialists and Research Institute
Gettysburg, Pennsylvania, United States
NEXT Virginia
Fairfax, Virginia, United States
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
Time frame: During the DLT period (28 days)
Phase 2 Dose Expansion: Prostate-specific antigen (PSA)-response rate (PSA-RR)
PSA per standard criteria
Time frame: Every 4 weeks throughout study treatment, an average of 6 months
Phase 2 Dose Expansion: Objective response rate (ORR)
ORR per standard criteria
Time frame: Every 8 weeks throughout study treatment, an average of 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.