Carolina BioOncology Institute | Huntersville, NC
Status and phase
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About
NUV-868-01 is a first-in human, open- label, Phase 1/2 dose escalation and expansion study in patients with advanced solid tumors. The Phase 1 and 1b portions include patients with advanced solid tumors and are designed to determine the safety and the dose(s) of NUV-868 to be used as monotherapy and in combination with olaparib or enzalutamide for the Phase 2 portion. In Phase 2, NUV-868 in combination with olaparib or enzalutamide will be given to determine the safety and efficacy of these study treatments. One cohort of patients (with enzalutamide-naïve metastatic castration-resistant prostate cancer) will be randomized to receive either NUV-868 monotherapy, enzalutamide monotherapy, or the combination of NUV-868 + enzalutamide. Patients will self-administer NUV-868 orally daily in 28-day cycles as monotherapy in Phases 1 and 2. In Phases 1b and 2, patients will self-administer NUV-868 orally daily in 28-day cycles in combination with olaparib or enzalutamide daily at standard prescribed doses (Phase 1b) or at the recommended Phase 2 combination dose (RP2cD) that is determined in Phase 1b. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.
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Inclusion and exclusion criteria
Key Inclusion Criteria For All Phases and Cohorts:
Cohort-Specific Inclusion Criteria: In addition to the inclusion criteria listed above, the following criteria apply for enrollment into specific cohorts.
Phase 1 (NUV-868 Monotherapy)
Phase 1b (NUV-868 in Combination With Enzalutamide or Olaparib)
Life expectancy of > 3 months
Eastern Cooperative Oncology Group Performance Status ≤ 2
(Select cohorts only) Measurable disease
Patient must be able to read and write sufficiently to document food intake and study drug dosing on the Dosing Diary or must have a caregiver who is willing and able to complete the Dosing Diary with the patient.
One of the following tumor types:
Phase 2
Life expectancy of > 6 months
(Select cohorts only): At least one measurable lesion defined by standard criteria
Eastern Cooperative Oncology Group Performance Status ≤ 1
One of the following tumor types:
Key Exclusion Criteria For All Phases and Cohorts:
Primary purpose
Allocation
Interventional model
Masking
657 participants in 7 patient groups
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Central trial contact
Nuvation Bio Inc.
Data sourced from clinicaltrials.gov
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