RecruitingPhase 1Phase 2NCT06616766

A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946

A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, PK and Anti-tumor Activity of YH42946 in Patients With Locally Advanced or Metastatic Solid Tumors With HER2 Aberration and EGFR Exon 20 Insertion


Sponsor

Yuhan Corporation

Enrollment

161 participants

Start Date

Oct 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this YH42946-101 is to evaluate the safety, Tolerability, Pharmacokinetics and anti-tumor activity of YH42946 in patients with locally advanced of metastatic solid tumors with HER2 aberration and EGFR exon 20 insertions.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This first-in-human study is testing a new drug called YH42946, which targets cancer cells with specific mutations in the HER2 or EGFR proteins. This early-phase trial is evaluating whether the drug is safe, how the body processes it, and whether it shows any early signs of fighting cancer in patients with solid tumors that have stopped responding to available treatments. **You may be eligible if...** - You are in good general health (ECOG score 0–1) - Your life expectancy is at least 3 months - You have a solid tumor that has progressed on or after all standard treatments, or for which standard treatment is not appropriate - You can provide a tumor tissue sample for HER2 or EGFR mutation testing - If you had brain metastases, they have already been treated - Your blood counts and organ function are within the required range **You may NOT be eligible if...** - You have active, untreated brain metastases - You have uncontrolled infections or serious autoimmune conditions - Your organ function does not meet required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGYH42946

YH42946


Locations(8)

Next Oncology Virginia

Fairfax, Virginia, United States

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

The Catholic Univ. of Korea St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Asan Medical Center, University of Ulsan

Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06616766


Related Trials