Phase 1 Brain Cancer Trial, Recruiting NCT07361562 Sponsor: Cogent Biosciences, Inc. Condition: Brain Cancer
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Phase 1 Brain Cancer Trial, Recruiting

NCT07361562
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have a confirmed diagnosis of an advanced, spreading, or inoperable solid tumour with specific genetic changes (called ERBB2-activating alterations, NRG1 gene fusions, or HER2 overexpression) detected in a blood or tumour test — this applies to Part A of the trial
  • People who have a confirmed diagnosis of advanced, spreading, or inoperable non-small cell lung cancer (a type of lung cancer) with a specific genetic change called an ERBB2 mutation detected in a blood or tumour test — this applies to Part B of the trial
  • People who have a confirmed diagnosis of advanced, spreading, or inoperable breast cancer with a specific ERBB2 genetic change or HER2 overexpression detected in a blood or tumour test — this applies to Part C of the trial
  • People whose cancer can be measured on scans according to a standard set of medical guidelines (called RECIST v1.1)
  • People who have a general health rating of 0 or 1 on a standard scale used by doctors (for Part A), or a rating of 0, 1, or 2 (for Parts B and C) — confirm exact details with the trial site
  • People whose recent blood and chemistry test results fall within acceptable ranges as determined by the trial site

Who may not be able to join:

  • People who have received certain chemotherapy, anti-cancer treatments, or radiation therapy within specific timeframes before the trial starts (confirm exact timeframes with the trial site)
  • People who have had major surgery — such as brain or chest surgery — within 4 weeks before the trial starts
  • People who have had focused radiation therapy to a small area (such as targeted brain or body radiation) within 2 weeks, or whole-brain radiation therapy within 4 weeks, before the trial starts
  • People who have a significant heart condition
  • People whose side effects from previous cancer treatments have not settled back to a mild level or to their baseline health before the trial starts
  • People who require corticosteroid medications (a type of anti-inflammatory drug) to manage neurological symptoms, depending on which part of the trial is being considered (confirm specific restrictions with the trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 617-945-5576

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Cogent Biosciences, Inc.
Registry
ClinicalTrials.gov
Start date
30 December 2025
Est. completion
1 May 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Part A]; Overall Response Rate [Part B and Part C]

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov