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

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.

Trial Details

NCT ID
NCT06616766
Phase
PHASE1 / PHASE2
Sponsor
Yuhan Corporation
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • YH42946
Locations (sample)
  • Fairfax, Virginia, United States|38.84622,-77.30637
  • Seongnam-si, Gyeonggi-do, South Korea|37.43861,127.13778
  • Suwon, Gyeonggi-do, South Korea|37.29111,127.00889
  • Cheongju-si, North Chungcheong, South Korea|36.63722,127.48972
  • Seoul, South Korea|37.566,126.9784

Key Eligibility Criteria

  • ECOG performance status 0 or 1
  • Estimated life expectancy of at least 3 months
  • Patients who have progressed on or after all available standard therapies or for whom standard treatment is inappropriate
  • Mandatory provision of archived or fresh tumor tissue in quantity sufficient to allow for retrospective confirmation of HER2 or EGFR mutation

For full eligibility, visit ClinicalTrials.gov.

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