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 (Sep 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
Documented HER2 aberration or EGFR mutation (HER2 mutation or EGFR exon 20 insertion, HER2 amplification or overexpression)
Required: HER2 (ERBB2) exon 20 insertion
HER2 exon 20 insertion (Cohort 1)
Required: HER2 (ERBB2) amplification
HER2 amplification
Required: HER2 (ERBB2) overexpression
HER2 overexpression
Required: EGFR mutation
EGFR mutation
Required: EGFR exon 20 insertion
EGFR exon 20 insertion
Disease stage
Required: Stage III, IV
locally advanced or metastatic solid tumors
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
Neutrophils ≥ 1.5 x10^9/L (no G-CSF within last week), platelets ≥ 75 x10^9/L, Hb ≥ 9g/dL (no pRBC transfusion within last week)
Kidney function
Serum creatinine ≤ 1.5 x ULN or eGFR > 60 mL/min per 1.73 m2
Liver function
Serum bilirubin ≤ 1.5 x ULN, AST or ALT ≤ 3 x ULN if no liver metastases, or ≤ 5 x ULN if due to liver metastases
Cardiac function
QTcF ≤ 470 ms, LVEF ≥ 50%
Adequate organ function defined as all of the following: ... (see above for details)
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 ERBB2?
Yes, ERBB2 exon 20 insertion is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification 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