NCT05252390

NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors

Phase 1/2 Safety and Efficacy Study of NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Nuvation Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study was initially planned as a Phase 1/2 study; however, the study stopped early prior to the start of Phase 2.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	NUV-868	NUV-868 is an investigational drug for oral dosing.
DRUG	Olaparib	Olaparib
DRUG	Enzalutamide	Enzalutamide

Timeline

• Start date: 2022-03-29
• Primary completion: 2024-07-15
• Completion: 2024-07-15
• First posted: 2022-02-23
• Last updated: 2025-11-06

Locations

22 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study