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NCT05252390 · ClinicalTrials.gov registry record · Phase 1
NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Nuvation Bio.
- Terminated
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
NCT05252390: Clinical Trial Phase 1 study, sponsored by Nuvation Bio.
NCT05252390 is a Phase 1 study that was terminated before completion, run by Nuvation Bio. The registered enrollment target is 82 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05252390, a Phase 1 study, was terminated before completion, sponsored by Nuvation Bio.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
Study 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.
Primary Outcome
Incidence of dose-limiting toxicities (DLTs)
Interventions
- DRUG Olaparib
- DRUG Enzalutamide
- DRUG NUV-868
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2022-03-29 |
| Est. Completion | 2024-07-15 |
| Phase | Phase 1 |
Why NCT05252390 stopped before completion
NCT05252390 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 3 interventions - of which Olaparib is the first listed.
NCT05252390 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05252390 about?
NCT05252390 is a clinical study titled "NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors". 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...
What is the current status of trial NCT05252390?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2022-03-29. Estimated completion is 2024-07-15.
What interventions are being tested in trial NCT05252390?
The interventions under investigation include: Olaparib (DRUG), Enzalutamide (DRUG), NUV-868 (DRUG).
Who is sponsoring clinical trial NCT05252390?
This trial is sponsored by Nuvation Bio, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05252390's enrollment target sits among peer trials
82 669th of 2000 higher than 1,330 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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