A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC
Recruiting
Phase 1
Interventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 110 (estimated)
- Sponsor
- EpiBiologics · Industry
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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.
Trial Locations
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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 ha…
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