NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT05252390. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05252390
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 82 participants
Conditions and interventions
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
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 28, 2022
- Primary completion
- Jul 14, 2024
- Completion
- Jul 14, 2024
- Last update posted
- Nov 5, 2025
2022 – 2024
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Arizona Cancer Center | Tucson | Arizona | 85724 | — |
| Ellison Institute of Technology | Los Angeles | California | 90064 | — |
| Rocky Mountain Cancer Centers, LLP | Aurora | Colorado | 80012 | — |
| Rocky Mountain Cancer Centers, LLP | Lone Tree | Colorado | 80124 | — |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Laura & Isaac Perlmutter Cancer Center - NYU Langone Health | New York | New York | 10016 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Carolina BioOncology Institute | Huntersville | North Carolina | 28078 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19104 | — |
| Sarah Cannon Research Institute - Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | — |
| Texas Oncology - Fort Worth Cancer Center | Fort Worth | Texas | 76104 | — |
| NEXT Virginia | Fairfax | Virginia | 22031 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05252390, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 5, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05252390 live on ClinicalTrials.gov.