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

ConditionsEpidermal Growth FactorEpidermal Growth Factor ReceptorEpidermal Growth Factor Receptor Gene MutationNon Small CellNon Small Cell LungNon Small Cell Lung CancerHead and NeckHead and Neck CancerHead and Neck CancersHead and Neck Squamous Cell CancerHead and Neck Squamous Cell CarcinomaHead and Neck Squamous Cell Carcinoma HNSCCNSCLC (Non-small Cell Lung Cancer)HNSCCEGFR
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEpiBiologics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant has a life expectancy > 12 weeks at Day 1.

Participant has an ECOG performance status of 0-2.

Participant has pathologically confirmed NSCLC or HNSCC.

Participant has locally advanced or metastatic NSCLC or HNSCC.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • EPI-326

    Drug

    EPI-326 is a tissue-selective bispecific antibody for EGFR-driven cancers. EPI-326 will be administered in the clinic via IV infusion.

Treatment groups

110 Participants
are divided into 1 treatment group
Group A: EPI-326Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluation 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.
2

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EpiBiologics

Lead sponsor

Source ClinicalTrials.gov
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