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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Advanced Solid Tumor
  • Breast Cancer
  • Breast Carcinoma
  • Breast Neoplasms
  • Breast Tumor
  • Cancer of Breast
  • Cancer of Ovary
  • Cancer of Pancreas
  • Cancer of Prostate
  • Cancer of the Breast
  • Cancer of the Ovary
  • Cancer of the Pancreas
  • Cancer of the Prostate
  • Castrate Resistant Prostate Cancer
  • Castration Resistant Prostatic Cancer
  • Castration Resistant Prostatic Neoplasms
  • Neoplasms
  • Ovarian Cancer
  • Ovarian Neoplasms
  • Ovary Cancer
  • Ovary Neoplasm
  • Pancreas Cancer
  • Pancreas Neoplasm
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Prostate Cancer
  • Prostate Neoplasm
  • Prostatic Cancer
  • Prostatic Neoplasms
  • Prostatic Neoplasms, Castration-Resistant
  • Triple Negative Breast Cancer
  • Triple Negative Breast Neoplasms
  • Triple-negative Breast Cancer

NCT number NCT05252390
Study type Interventional
Source Nuvation Bio Inc.
Contact Nuvation Bio Inc.
Phone 332-208-6102
Email clinicaltrials@nuvationbio.com
Status Recruiting
Phase Phase 1/Phase 2
Start date March 29, 2022
Completion date November 2026

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