EGFR, Epidermal Growth Factor, Epidermal Growth Factor Receptor, Epidermal Growth Factor Receptor Gene Mutation, 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, HNSCC, Non Small Cell, Non Small Cell Lung, Non Small Cell Lung Cancer, NSCLC (Non-small Cell Lung Cancer)
Conditions
Keywords
Head and Neck Squamous Cell Carcinoma, HNSCC, Epidermal Growth Factor Receptor Gene Mutation, EGFR, Non Small Cell Lung Cancer, NSCLC
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.
Interventions
DRUGEPI-326
EPI-326 is a tissue-selective bispecific antibody for EGFR-driven cancers. EPI-326 will be administered in the clinic via IV infusion.
Sponsors
EpiBiologics
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the safety and tolerability of EPI-326 | 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 | Up to 3 years. | Maximum tolerated dose (MTD), maximum administered dose (MAD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of maximum (Cmax) and minimum (Cmin) plasma concentration | Up to 3 years. | Drug concentration in the blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326. |
| Determination of area under the concentration-time curve (AUC) | Up to 3 years. | Drug concentration in blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326 |
| Determination of clearance (CL) from the blood | Up to 3 years. | Drug concentration in blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326 |
| Determination of volume of distribution (Vd) | Up to 3 years. | Drug concentration in blood. To evaluate the single and multiple dose pharmacokinetic (PK) profile of EPI-326 |
| Objective response rate (ORR) | Up to 3 years. | — |
| Duration of response (DOR) | Up to 3 years. | — |
Countries
United States
Contacts
CONTACTEpiBiologics Clinical Trials
Outcome results
None listed