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NCT07361562 · ClinicalTrials.gov registry record · Phase 1
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and ERBB2 Gene Amplification, sponsored by Cogent Biosciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 6
- Study locations
NCT07361562: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and ERBB2 Gene Amplification, sponsored by Cogent Biosciences.
NCT07361562 is a Phase 1 study of Non-Small Cell Lung Cancer and ERBB2 Gene Amplification that is actively recruiting participants, run by Cogent Biosciences. The registered enrollment target is 100 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07361562, a Phase 1 study of Non-Small Cell Lung Cancer and ERBB2 Gene Amplification, is actively recruiting participants, sponsored by Cogent Biosciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is an open-label, phase 1/1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult participants with advanced solid tumors with ERBB2 alterations or HER2 overexpression.
Primary Outcome
1\. 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) in participants with ERBB2-altered advanced solid tumors
Conditions Studied
Interventions
- DRUG CGT4255
Study Locations (6)
Michigan
- START Midwest - Grand Rapids
New York
- NYU Langone - New York
Tennessee
- Tennessee Oncology - Nashville
Texas
- NEXT Oncology Texas - Austin
Utah
- START Mountain Region - West Valley City
Virginia
- NEXT Oncology Virginia - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-12-30 |
| Est. Completion | 2028-11 |
| Phase | Phase 1 |
What NCT07361562 shows while recruiting
NCT07361562 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower).
The record links to 6 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which CGT4255 is the first listed.
NCT07361562 lists 6 locations in 6 states (Michigan, New York, Tennessee).
Frequently Asked Questions
What is clinical trial NCT07361562 about?
NCT07361562 is a clinical study titled "A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors". This is an open-label, phase 1/1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult participants with advanced solid tumors with ERBB2 alterations or HER2 overexpre...
What is the current status of trial NCT07361562?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2025-12-30. Estimated completion is 2028-11.
What conditions does trial NCT07361562 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, ERBB2 Gene Amplification, HER2, Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer.
What interventions are being tested in trial NCT07361562?
The interventions under investigation include: CGT4255 (DRUG).
Who is sponsoring clinical trial NCT07361562?
This trial is sponsored by Cogent Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07361562 being conducted?
This trial has 6 study locations across Michigan, New York, Tennessee, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07361562's enrollment target sits among peer trials
100 233rd of 454 higher than 212 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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