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RECRUITING Phase 1

A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors

NCT07361562 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 100 participants
Start Date 2025-12-30
Est. Completion 2028-11
Phase Phase 1

Sponsor

Cogent Biosciences

64 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cogent Biosciences, which has 64 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07361562 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Michigan, New York, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07361562?

The interventions under investigation include: CGT4255 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07361562?

This trial is sponsored by Cogent Biosciences, which has 64 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial