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
Yuhan Corporation
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.
Description
YH42946 is a novel, orally available tyrosine kinase inhibitor targeting HER2. YH42946 showed potency for diverse HER2 aberrations including HER2 overexpression, amplification, or mutation, as well as EGFR Ex20ins. This is a Phase 1/2, open-label, multicenter, first-in-human study of YH42946. The study has 2 parts. The first part is dose escalation part to identify the maximum tolerated dose. The second part is dose expansion part to select 2 doses for RD selection at the first cohort, after then RD will be determined to ensure its efficacy. Several independent cohorts are planned.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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 * A patient with a history of brain metastases must have had all lesions treated * Adequate organ function defined as all of the following: * Adequate bone marrow function (within 1 week prior to first administration): Neutrop…
Interventions
- DrugYH42946
YH42946
Locations (8)
- Next Oncology VirginiaFairfax, Virginia
- Seoul National University Bundang HospitalSeongnam-si, Gyeonggi-do
- The Catholic Univ. of Korea St. Vincent's HospitalSuwon, Gyeonggi-do
- Chungbuk National University HospitalCheongju-si, North Chungcheong
- Seoul National University HospitalSeoul
- Severance Hospital, Yonsei UniversitySeoul