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ERBB2 Altered Breast Cancer / Advanced Solid Tumor, Adult / ERBB2 Gene Amplification · Phase 1 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1/1b trial registration for CGT4255, a selective ERBB2 inhibitor in patients with advanced solid tumors harboring ERBB2 alterations or HER2 overexpression. The study is currently recruiting with no results yet posted; it is designed to evaluate safety, tolerability, and early antitumor activity over approximately 12 months (Part A) and 6 months (Parts B and C).
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression, Non-Small Cell Lung Cancer, HER2; age from 18 Years. Intervention: Dose Escalation; Signal Seeking and Dose Escalation; Signal Seeking. n = 100. 15 sites: United States.
This is a Phase 1/1b trial registration for CGT4255, a selective ERBB2 inhibitor in patients with advanced solid tumors harboring ERBB2 alterations or HER2 overexpression. The study is currently recruiting with no results yet posted; it is designed to evaluate safety, tolerability, and early antitumor activity over approximately 12 months (Part A) and 6 months (Parts B and C).
Open-label design (no blinding); may introduce bias in safety and efficacy assessments. Primary endpoints include both safety (Part A) and efficacy (Parts B and C); no efficacy data yet available to assess clinical benefit.
This trial is in early recruitment and has not yet generated clinical data. Clinicians should monitor for future results but cannot base treatment decisions on this registry record.
Phase 1/1b trial registration with no reported results; the study is actively recruiting and designed to evaluate safety and early antitumor activity in a small population.
As stated by the source record.
Quoted from the source exactly as published.
This trial is in early recruitment and has not yet generated clinical data. Clinicians should monitor for future results but cannot base treatment decisions on this registry record.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07361562). This is a study registration, not published results. Lead sponsor: Cogent Biosciences, Inc.. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression, Non-Small Cell Lung Cancer, HER2. Interventions: DRUG: CGT4255. Primary outcome measures: Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Part A] , Approximately 12 months; Overall Response Rate [Part B and Part C] , Approximately 6 months. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.