NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
Stopped early · Phase 1
Conditions studied: Advanced Solid Tumor, Ovarian Cancer, Ovary Cancer, Cancer of Ovary, Cancer of the Ovary, Ovary Neoplasm, Pancreatic Cancer, Pancreas Cancer, Cancer of Pancreas, Cancer of the Pancreas, Pancreas Neoplasm, 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, Triple-negative Breast Cancer, Triple Negative Breast Cancer, Triple Negative Breast Neoplasms, Breast Cancer, Breast Carcinoma, Cancer of Breast, Cancer of the Breast, Breast Tumor
In brief
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.
Key facts
- Study ID
- NCT05252390
- Run by
- Nuvation Bio Inc.
- People needed
- 82
- Starts
- 2022-03-29
- Expected to finish
- 2024-07-15
- Last updated by the study team
- 2025-11-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The University of Arizona Cancer Center — Tucson, Arizona, United States
- Ellison Institute of Technology — Los Angeles, California, United States
- Rocky Mountain Cancer Centers, LLP — Aurora, Colorado, United States
- Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado, United States
- H. Lee Moffitt Cancer Center — Tampa, Florida, United States
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Laura & Isaac Perlmutter Cancer Center - NYU Langone Health — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Carolina BioOncology Institute — Huntersville, North Carolina, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- Sarah Cannon Research Institute - Tennessee Oncology — Nashville, Tennessee, United States
- Mary Crowley Cancer Research — Dallas, Texas, United States
- Texas Oncology - Fort Worth Cancer Center — Fort Worth, Texas, United States
- NEXT Virginia — Fairfax, Virginia, United States
- Virginia Oncology Associates — Norfolk, Virginia, United States
- Macquarie University Hospital — North Ryde, New South Wales, Australia
- Calvary Mater Hospital Newcastle — Waratah, New South Wales, Australia
- Cabrini Hospital Malvern — Malvern, Victoria, Australia
- Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia
- Linear Clinical Research — Nedlands, Western Australia, Australia
Full record on ClinicalTrials.gov
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