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 (Jun 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
Treatments studied
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06616766 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ERBB2?
Yes, ERBB2 mutation is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR mutation is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR exon 20 insertion is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify