🏛️ Verified NIH Record • Updated 2026-08-13

A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946 (NCT06616766)

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Yuhan Corporation

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (15 items) and avoid the listed exclusions (15 items).

Location: Next Oncology Virginia — Fairfax, Virginia

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Patient with symptomatic or progressive brain metastases
  • Known or suspected leptomeningeal disease (LMD)
  • Uncontrolled spinal cord compression
  • History of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks
  • History of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
  • Medical, psychiatric, cognitive or other conditions that compromise the patients ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study
  • Any severe concurrent disease or condition (includes active infections, cardiac arrhythmia) that in the judgment of the Investigator would make study participation inappropriate for the patient
  • History of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or any evidence of current ILD or pneumonitis
  • History of a second primary cancer with the exception of
  • curatively treated non-melanomatous skin cancer,
  • curatively treated cervical or breast carcinoma in situ, or

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (8 Sites)

  • Next Oncology Virginia — Fairfax, Virginia
  • Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do
  • The Catholic Univ. of Korea St. Vincent's Hospital — Suwon, Gyeonggi-do
  • Chungbuk National University Hospital — Cheongju-si, North Chungcheong
  • Seoul National University Hospital — Seoul,
  • Severance Hospital, Yonsei University — Seoul,
  • Samsung Medical Center — Seoul,
  • Asan Medical Center, University of Ulsan — Seoul,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗