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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
EPI-326 is a tissue-selective bispecific antibody for EGFR-driven cancers. EPI-326 will be administered in the clinic via IV infusion.
START Los Angeles
Los Angeles, California, United States
NOT_YET_RECRUITINGAstera Cancer Care
East Brunswick, New Jersey, United States
NOT_YET_RECRUITINGSarah Cannon and HCA Research Institute
Nashville, Tennessee, United States
NOT_YET_RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
NOT_YET_RECRUITINGSouth Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
RECRUITINGEvaluation of the safety and tolerability of EPI-326
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicity (DLTs).
Time frame: Up to 3 years.
Determination of the recommended dose and schedule for EPI-326 administration
Maximum tolerated dose (MTD), maximum administered dose (MAD).
Time frame: Up to 3 years.
Determination of maximum (Cmax) and minimum (Cmin) plasma concentration
Drug concentration in the blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326.
Time frame: Up to 3 years.
Determination of area under the concentration-time curve (AUC)
Drug concentration in blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326
Time frame: Up to 3 years.
Determination of clearance (CL) from the blood
Drug concentration in blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326
Time frame: Up to 3 years.
Determination of volume of distribution (Vd)
Drug concentration in blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326
Time frame: Up to 3 years.
Objective response rate (ORR)
Time frame: Up to 3 years.
Duration of response (DOR)
Time frame: Up to 3 years.
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