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Recruiting
NCT07462377
A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
Conditions: Epidermal Growth Factor, Epidermal Growth Factor Receptor, Epidermal Growth Factor Receptor Gene Mutation, Non Small Cell, Non Small Cell Lung, Non Small Cell Lung Cancer, 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, NSCLC (Non-small Cell Lung Cancer), HNSCC, EGFR
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 110
Sponsor: EpiBiologics
Location: START Los Angeles Los Angeles California
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07462377). StuddyBuddy aggregates publicly available trial information.
