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YH42946 for Advanced Solid Tumors with HER2 or EGFR Mutations

This study is testing a new medication called YH42946 for people with advanced solid tumors, including non-small cell lung cancer (NSCLC), that have specific changes (aberrations) in the HER2 or EGFR genes. YH42946 is a type of drug called a tyrosine kinase inhibitor, which works by blocking signals that can cause cancer cells to grow. The main goals are to see how safe YH42946 is, how well your body handles it, and if it can shrink tumors. To join, you must be at least 18 years old, have a good general health status (ECOG performance status 0 or 1), and have cancer that has progressed after standard treatments or for which standard treatment isn't appropriate. You will also need to provide a tumor tissue sample to confirm the HER2 or EGFR mutation.

Study design
This is a Phase 1/2, open-label (meaning you and your doctors will know what treatment you are receiving), multicenter study. It plans to enroll 161 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects through completion, and tumor response will be measured for approximately 12 months during the dose expansion part.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06616766

A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946

Recruiting
PHASE1Ages 18+InterventionalTreatment
Yuhan Corporation
~201 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:YH42946

At a glance

Recruiting sites
7 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment Emergent Adverse Events(TEAE)s
Measured over Through study completion, during the first 21 days of DLT evaluation period.
+1 more outcome measured

Conditions

NSCLC (Non-small Cell Lung Cancer)
Solid Tumor

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Where it's being run

8 sites across 4 states
South Korea4
Gyeonggi-do2
Virginia1
North Chungcheong1

Study leadership

  • Jeesun Lee, MD · STUDY_DIRECTOR · Yuhan Corporation

Who to contact

Yuhan Corporation Clinical Operation Team 1
[email protected]
8228280576
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 aberration 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 must be met without packed red blood cell (pRBC) transfusion within last week prior to testing.)
Adequate hepatic function: Serum bilirubin≤1.5 x upper limit of normal (ULN), and serum transaminase (either aspartate transaminase (AST) or alanine transaminase (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 renal function: Serum creatinine ≤ 1.5 x ULN or Estimated glomerular filtration rate (eGFR) \> 60 mL/min per 1.73 m\*2 according to the site's calculation method.
Adequate Heart function: QTcF≤ 470 ms, LVEF≥ 50%
Blood Coagulation: INR or Prothrombin time ≤ 1.5 X ULN, aPTT ≤ 1.5 X ULN
Histologically or cytologically confirmed diagnosis of advanced, and/or metastatic non-hematologic malignancy
Documented HER2 aberration or EGFR mutation (HER2 mutation or EGFR exon 20 insertion, HER2 amplification or overexpression)
Patients who have at least 1 measurable lesion
Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC HER2 exon 20 insertion (Cohort 1)

Exclusion

Patient with symptomatic or progressive brain metastases
Known or suspected leptomeningeal disease (LMD)
Uncontrolled spinal cord compression
History of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks
History of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
Medical, psychiatric, cognitive or other conditions that compromise the patients ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study
Any severe concurrent disease or condition (includes active infections, cardiac arrhythmia) that in the judgment of the Investigator would make study participation inappropriate for the patient
History of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or any evidence of current ILD or pneumonitis
History of a second primary cancer with the exception of
Infection with Human immunodeficiency virus (HIV) infection, or active chronic hepatitis B or chronic hepatitis C
Major surgery within 4 weeks prior to the first dose of study treatment

What this trial measures

  • Treatment Emergent Adverse Events(TEAE)sThrough study completion, during the first 21 days of DLT evaluation period.

    To assess the safety and tolerability of YH42946

  • Objective Response Rate (ORR)Through dose expansion part completion, approximately 12 months

    Anti-tumor activity according to RECIST v1.1