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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 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 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower). The trial reports 6 study locations across 6 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07361562
The ClinicalTrials.gov registry entry for NCT07361562 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower). The listed sponsor is Cogent Biosciences, which has 12 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.
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