Clinical trial · Interventional
A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
A First-in-Human, Open-label, Multicenter, Phase 1 Study of EPI-326 in Patients With Epidermal Growth Factor Receptor-Mutant Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma
NCT07462377CI-TRIAL-00116824recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR | — | UNRESOLVED | — |
| Epidermal Growth Factor | — | UNRESOLVED | — |
| Epidermal Growth Factor Receptor | — | UNRESOLVED | — |
| Epidermal Growth Factor Receptor Gene Mutation | — | UNRESOLVED | — |
| Head and Neck | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Head and Neck Squamous Cell Cancer | — | UNRESOLVED | — |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Squamous Cell Carcinoma HNSCC | — | UNRESOLVED | — |
| HNSCC | Head and Neck Squamous Cell Carcinoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EPI-326 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EPI-326
- description
- Experimental: Dose Escalation
- interventionNames
- Drug: EPI-326
Primary outcomes (2)
- measure
- Evaluation of the safety and tolerability of EPI-326
- timeFrame
- Up to 3 years.
- description
- Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicity (DLTs).
- measure
- Determination of the recommended dose and schedule for EPI-326 administration
- timeFrame
- Up to 3 years.
- description
- Maximum tolerated dose (MTD), maximum administered dose (MAD).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participant has a life expectancy \> 12 weeks at Day 1. 2. Participant has an ECOG performance status of 0-2. 3. Participant has pathologically confirmed NSCLC or HNSCC. o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion. 4. Participant has locally advanced or metastatic NSCLC or HNSCC. 5. Participant has adequate organ function Exclusion Criteria: 1. Participant has history of uncontrolled illness. 2. Participant has symptomatic brain metastases. 3. Participant has a diagnosis of any secondary malignancy within 3 years prior to enrollment, except for those patients treated with curative intent and no evidence of active disease.
References
Publications (0)
Data not yet available
No reference posted for this study.