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NCT07570979 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 208
- Enrollment target
NCT07570979: Recruiting Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT07570979 is a Phase 1 study that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 208 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (247% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07570979, a Phase 1 study, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 208 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, preliminary anti-tumor activity, and recommended dose of INR731 as a single agent and in combination with standard-of-care androgen receptor pathway inhibitors (ARPIs) in adult patients with metastatic prostate cancer.
Primary Outcome
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 that occurs within the first 28 days and not clearly and incontrovertibly assessed as due to disease progression, intercurrent illness, concomitant medication, or extraneous causes with the exceptions defined in the study protocol. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Interventions
- DRUG Enzalutamide
- DRUG Abiraterone
- DRUG Androgen deprivation therapy (ADT)
- DRUG INR731
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2026-05-25 |
| Est. Completion | 2030-06-03 |
| Phase | Phase 1 |
What NCT07570979 shows while recruiting
NCT07570979 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (247% higher).
The record links to 0 conditions, and to 4 interventions - of which Enzalutamide is the first listed.
NCT07570979 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07570979 about?
NCT07570979 is a clinical study titled "A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer". The purpose of this study is to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, preliminary anti-tumor activity, and recommended dose of INR731 as a single agent and in combination with standard-of-care androgen receptor pathway inhibitors (ARPIs) in adult patients with metastati...
What is the current status of trial NCT07570979?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 208 participants. The study started on 2026-05-25. Estimated completion is 2030-06-03.
What interventions are being tested in trial NCT07570979?
The interventions under investigation include: Enzalutamide (DRUG), Abiraterone (DRUG), Androgen deprivation therapy (ADT) (DRUG), INR731 (DRUG).
Who is sponsoring clinical trial NCT07570979?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07570979's enrollment target sits among peer trials
208 250th of 2000 higher than 1,749 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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