A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC

EpiBiologics

Status and phase: Begins enrollment this month; Phase 1

Conditions: EGFR; Non Small Cell; HNSCC; NSCLC (Non-small Cell Lung Cancer); Head and Neck Squamous Cell Cancer; Head and Neck Cancers; Non Small Cell Lung Cancer; Head and Neck; Non Small Cell Lung; Epidermal Growth Factor Receptor Gene Mutation; Epidermal Growth Factor; Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma HNSCC; Epidermal Growth Factor Receptor; Head and Neck Squamous Cell Carcinoma

Treatments: Drug: EPI-326

Study type: Interventional

Funder types: Industry

Identifiers

NCT07462377

EPI-326-001

Details and patient eligibility

About

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.

Full description

This study will be a first-in-human (FIH), Phase 1, multicenter, open-label study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 as a single agent administered to patients with EGFR-mutant (per clinically validated molecular testing, e.g., next-generation sequencing [NGS]) locally advanced or metastatic NSCLC and locally advanced or metastatic HNSCC. All patients will be treated until documented disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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110 participants in 1 patient group

EPI-326

Experimental group

Description:

Experimental: Dose Escalation

Treatment:

Drug: EPI-326