EPI-326 for Lung Cancer and Head and Neck Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called EPI-326 for individuals with certain advanced or metastatic cancers, specifically lung cancer with an EGFR mutation and head and neck cancers. The primary goal is to determine the safety of EPI-326 and how the body responds to it, while also assessing its effectiveness against cancer. It suits those diagnosed with advanced lung cancer with an EGFR mutation or head and neck cancer who can still perform daily activities. As a Phase 1 trial, this research aims to understand how EPI-326 works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that EPI-326 is likely to be safe for humans?
Research has shown that EPI-326 underwent lab testing before human trials. These tests found EPI-326 effective against cancer cells with minimal harm. However, since human testing has just begun, limited information exists about its safety in people. This first phase of human trials aims to assess its safety and tolerability. Researchers closely monitor any side effects and how well participants handle the treatment. So far, no major safety issues have emerged, but data collection continues. Prospective participants should understand that this trial is part of the process to determine EPI-326's safety for cancer treatment.12345
Why do researchers think this study treatment might be promising?
Most treatments for lung cancer and head and neck cancers focus on approaches like chemotherapy, radiation, or surgery, which target rapidly dividing cells or remove tumors. EPI-326 is unique because it introduces a new mechanism of action by specifically targeting molecular pathways that are crucial for cancer cell survival and growth. This precision approach aims to minimize damage to healthy cells and reduce side effects, which is a significant improvement over traditional therapies. Researchers are excited about EPI-326 because it has the potential to be more effective and less harmful, offering a new hope for patients with these types of cancer.
What evidence suggests that EPI-326 might be an effective treatment for lung cancer and head and neck cancers?
Research has shown that EPI-326 delivers promising results in early lab studies. It effectively fights tumors in models of EGFR-mutant non-small cell lung cancer (NSCLC), even when current treatments fail. This trial will evaluate EPI-326 for its potential to treat certain lung and head and neck cancers. The compound works by breaking down EGFR, a protein that often promotes cancer growth. Although most current data comes from lab studies, these early results are encouraging for its potential use in people.13467
Are You a Good Fit for This Trial?
This trial is for adults with advanced or spreading non-small cell lung cancer (NSCLC) that has an EGFR mutation, or head and neck squamous cell carcinoma (HNSCC). Participants must have good organ function, be able to care for themselves most of the time, and not have uncontrolled illnesses or active brain tumors.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ascending doses of EPI-326 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EPI-326
Trial Overview
The study is testing different increasing doses of a new drug called EPI-326 to see if it is safe and how well patients tolerate it. The trial also looks at how the body processes the drug and its early effects on tumors in people with these cancers.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Experimental: Dose Escalation
Find a Clinic Near You
Who Is Running the Clinical Trial?
EpiBiologics
Lead Sponsor
Citations
A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and ...
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 ...
2.
biopharmaapac.com
biopharmaapac.com/news/32/7842/epibiologics-advances-tissue-selective-egfr-degrader-epi-326-into-first-in-human-clinical-study.htmlEpiBiologics Advances Tissue Selective EGFR Degrader ...
Broad anti-tumor activity: EPI-326 showed robust preclinical in vivo efficacy in both classical and drug-resistant (C797S) EGFR-mutant NSCLC ...
3.
finance.yahoo.com
finance.yahoo.com/sectors/healthcare/articles/epibiologics-doses-first-patient-epi-213000843.htmlEpiBiologics Doses First Patient with EPI-326 Bispecific ...
Broad anti-tumor activity: EPI-326 showed robust preclinical in vivo efficacy in both classical and drug-resistant (C797S) EGFR-mutant NSCLC ...
Biologic degraders push forward in the clinic
A handful of antibody-based extracellular targeted protein degraders are advancing in the clinic, highlighting emerging opportunities to ...
A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and ...
A phase 1 study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 ...
EpiBiologics Doses First Patient with EPI-326 Bispecific ...
The Phase 1 study (NCT07462377) is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of EPI- ...
7.
ddw-online.com
ddw-online.com/biotech-startup-raises-107m-to-advance-oncology-candidates-39852-202601/Biotech startup raises $107m to advance oncology ...
In preclinical studies, EPI-326 showed its strong and durable efficacy with favourable safety and pharmacokinetics, enabling both monotherapy ...
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