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NCT07383506 · ClinicalTrials.gov registry record · Phase 1
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Cogent Biosciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
NCT07383506: Recruiting Phase 1 study, sponsored by Cogent Biosciences.
NCT07383506 is a Phase 1 study that is actively recruiting participants, run by Cogent Biosciences. The registered enrollment target is 90 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07383506, a Phase 1 study, is actively recruiting participants, sponsored by Cogent Biosciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
Study Summary
This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of CGT6297 in adult participants with advanced solid tumors harboring PIK3CA mutations
Primary Outcome
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) and AEs leading to dose modifications and dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD) or the maximum evaluated dose (MED) of CGT6297 in participants with advanced solid tumors harboring PIK3CA mutations
Interventions
- DRUG CGT6297
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2026-06 |
| Est. Completion | 2029-08 |
| Phase | Phase 1 |
What NCT07383506 shows while recruiting
NCT07383506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 1 intervention - of which CGT6297 is the first listed.
NCT07383506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07383506 about?
NCT07383506 is a clinical study titled "A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors". This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of CGT6297 in adult participants with advanced solid tumors harboring PIK3CA ...
What is the current status of trial NCT07383506?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2026-06. Estimated completion is 2029-08.
What interventions are being tested in trial NCT07383506?
The interventions under investigation include: CGT6297 (DRUG).
Who is sponsoring clinical trial NCT07383506?
This trial is sponsored by Cogent Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07383506's enrollment target sits among peer trials
90 628th of 2000 higher than 1,352 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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