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Epidermal Growth Factor Receptor / Epidermal Growth Factor / EPI-326 · Phase 1 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 clinical trial registration for EPI-326, an investigational drug, in patients with EGFR-mutant NSCLC and HNSCC. The study is currently recruiting and has not yet reported results. No efficacy or safety outcomes are available from this registry record.
Phase 1, Interventional, Sequential, Open label, Treatment purpose. Epidermal Growth Factor, Epidermal Growth Factor Receptor, Epidermal Growth Factor Receptor Gene Mutation, Non Small Cell, Non Small Cell Lung, Non Small Cell…; age from 18 Years. Intervention: EPI-326. n = 110. 6 sites: United States.
This is a Phase 1 clinical trial registration for EPI-326, an investigational drug, in patients with EGFR-mutant NSCLC and HNSCC. The study is currently recruiting and has not yet reported results. No efficacy or safety outcomes are available from this registry record.
Study is currently recruiting; no safety, tolerability, or efficacy data are available.
The source did not state who this applies to in practice.
Phase 1 study in early development stage with no results yet reported; designed to assess safety, tolerability, and dose-finding in a small patient population with EGFR-mutant NSCLC and HNSCC.
As stated by the source record.
Quoted from the source exactly as published.
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 (NCT07462377). This is a study registration, not published results. Lead sponsor: EpiBiologics. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 110 participants (ESTIMATED). Conditions: Epidermal Growth Factor, Epidermal Growth Factor Receptor, Epidermal Growth Factor Receptor Gene Mutation, Non Small Cell, Non Small Cell Lung, Non Small Cell Lung Cancer, Head and Neck, Head and Neck Cancer, Head and Neck Cancers, Head and Neck Squamous Cell Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma HNSCC, NSCLC (Non-small Cell Lung Cancer), HNSCC, EGFR. Interventions: DRUG: EPI-326. Primary outcome measures: Evaluation of the safety and tolerability of EPI-326 , Up to 3 years.; Determination of the recommended dose and schedule for EPI-326 administration , Up to 3 years.. Brief summary: A phase 1 study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 administered to patients with locally advanced or metastatic HNSCC and to patients with any documented EGFR-mutant locally advanced or metastatic NSCLC.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.