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
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- EpiBiologics
- Enrollment
- 110
- Locations
- 5
- Primary Endpoint
- Evaluation of the safety and tolerability of EPI-326
Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant has a life expectancy \> 12 weeks at Day
- •Participant has an ECOG performance status of 0-
- •Participant has pathologically confirmed NSCLC or HNSCC.
- •o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion.
- •Participant has locally advanced or metastatic NSCLC or HNSCC.
- •Participant has adequate organ function
Exclusion Criteria
- •Participant has history of uncontrolled illness.
- •Participant has symptomatic brain metastases.
- •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.
Arms & Interventions
EPI-326
Experimental: Dose Escalation
Intervention: EPI-326 (Drug)
Outcomes
Primary Outcomes
Evaluation of the safety and tolerability of EPI-326
Time Frame: Up to 3 years.
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicity (DLTs).
Determination of the recommended dose and schedule for EPI-326 administration
Time Frame: Up to 3 years.
Maximum tolerated dose (MTD), maximum administered dose (MAD).
Secondary Outcomes
- Determination of maximum (Cmax) and minimum (Cmin) plasma concentration(Up to 3 years.)
- Determination of area under the concentration-time curve (AUC)(Up to 3 years.)
- Determination of clearance (CL) from the blood(Up to 3 years.)
- Determination of volume of distribution (Vd)(Up to 3 years.)
- Objective response rate (ORR)(Up to 3 years.)
- Duration of response (DOR)(Up to 3 years.)