EPI-326 for Lung Cancer and Head and Neck Cancers

Recruiting at 5 trial locations

Overseen By EpiBiologics Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: EpiBiologics

Disqualifiers: Uncontrolled illness, Brain metastases, Secondary malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 years

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

Inclusion Criteria

My organs are working well enough for treatment.

Participant has a life expectancy > 12 weeks at Day 1

I have advanced or metastatic lung or head and neck cancer.

Exclusion Criteria

Participant has history of uncontrolled illness

I have not had another cancer in the past 3 years, unless it was cured and is inactive.

I have brain metastases that are causing symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ascending doses of EPI-326 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EPI-326

How Is the Trial Designed?

Group I: EPI-326 Experimental Treatment 1 Intervention

Experimental: Dose Escalation

Who Is Running the Clinical Trial?

EpiBiologics

Lead Sponsor