OncoMatch/Clinical Trials/NCT06616766
A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946
Is NCT06616766 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies YH42946 for nsclc (non-small cell lung cancer).
Treatment: 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) mutation
Mandatory provision of archived or fresh tumor tissue in quantity sufficient to allow for retrospective confirmation of HER2 or EGFR mutation
Required: EGFR mutation
Mandatory provision of archived or fresh tumor tissue in quantity sufficient to allow for retrospective confirmation of HER2 or EGFR mutation
Required: EGFR exon 20 insertion
EGFR exon 20 insertion
Required: HER2 (ERBB2) mutation
HER2 mutation
Required: HER2 (ERBB2) exon 20 insertion
HER2 exon 20 insertion
Required: HER2 (ERBB2) amplification
HER2 amplification
Required: HER2 (ERBB2) overexpression
HER2 overexpression
Disease stage
Required: Stage III, IV
locally advanced or metastatic NSCLC HER2 exon 20 insertion (Cohort 1); advanced, and/or metastatic non-hematologic malignancy
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
Neutrophils ≥ 1.5 x10^9 cells/L (without G-CSF within last week prior to testing); platelet count ≥ 75 x10^9 cells/L; Hb ≥ 9g/dL (without pRBC transfusion within last week prior to testing)
Kidney function
Serum creatinine ≤ 1.5 x ULN or eGFR > 60 mL/min per 1.73 m2 according to the site's calculation method
Liver function
Serum bilirubin ≤ 1.5 x ULN, and serum transaminase (AST or ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases (within 1 week prior to first administration)
Adequate organ function defined as all of the following: Adequate bone marrow function... Adequate hepatic function... Adequate renal function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Next Oncology Virginia · Fairfax, Virginia
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