A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and A
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.
| Condition(s) | NSCLC (Non-small Cell Lung Cancer), Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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): Neutrophils≥1.5 x10\*9 cells/L (Criteria must be met without the use of Granulocyte-Colony Stimulating Factor (G-CSF) within last week prior to testing.); platelet count≥75 x10\*9 cells/L; Hb ≥9g/dL (Criteria mu |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Yuhan Corporation |
| Locations | Fairfax, Virginia, United States; Seongnam-si, Gyeonggi-do, South Korea; Suwon, Gyeonggi-do, South Korea; Cheongju-si, North Chungcheong, South Korea; Seoul, South Korea; Seoul, South Korea (+2 more sites) |
| Start date | 2024-10-02 |
| NCT ID | NCT06616766 |
| Official listing | https://clinicaltrials.gov/study/NCT06616766 |