Actively Recruiting
A Phase 1/2, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of YH42946 in Patients With Locally Advanced or Metastatic Solid Tumors With HER2 Aberration and EGFR Exon 20 Insertion
Led by Yuhan Corporation · Updated on 2025-11-04
161
Participants Needed
8
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating YH42946, a new oral drug that targets HER2 and EGFR exon 20 insertions in patients with locally advanced or metastatic solid tumors. This Phase 1/2, open-label, multicenter study aims to assess the safety, tolerability, how the body processes the drug, and its anti-tumor activity. The study is sponsored by Yuhan Corporation and focuses on patients whose tumors have specific genetic changes involving HER2 and EGFR. The study has two parts. The first part involves gradually increasing doses of YH42946 to find the highest dose patients can tolerate safely. The second part expands the study to test selected doses in several patient groups to determine the recommended dose for future studies. Participants will receive YH42946 orally as the investigational treatment throughout these phases. Participants will undergo regular assessments including monitoring for side effects during the first 21 days, and evaluation of tumor response over about 12 months. Researchers will collect blood samples to study how the drug moves through and affects the body. Safety and treatment effects will be closely tracked to guide dosing decisions and understand the drug's impact. The total study duration varies depending on individual participation in dose escalation and expansion phases.
CONDITIONS
Brief Title
A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 sufficient to confirm HER2 or EGFR mutation
- History of brain metastases must have had all lesions treated
- Adequate bone marrow function: Neutrophils ≥1.5 x10^9 cells/L without recent G-CSF; platelet count ≥75 x10^9 cells/L; hemoglobin ≥9 g/dL without recent transfusion
- Adequate hepatic function: Serum bilirubin ≤1.5 x upper limit of normal, AST or ALT ≤3 x ULN without liver metastases or ≤5 x ULN with liver metastases
- Adequate renal function: Serum creatinine ≤1.5 x ULN or eGFR > 60 mL/min per 1.73 m²
- Histologically or cytologically confirmed advanced non-hematologic malignancy with documented HER2 or EGFR mutation (Dose Escalation part only)
- Patients with locally advanced or metastatic NSCLC with HER2 exon 20 insertion (Dose Expansion part only)
You will not qualify if you...
- Symptomatic or progressive brain metastases
- Known or suspected leptomeningeal disease
- Uncontrolled spinal cord compression
- History of acute coronary syndromes or major heart procedures within past 24 weeks
- History or current severe heart failure (Class II-IV NYHA)
- Medical, psychiatric, or cognitive conditions that impair informed consent or study compliance
- Severe concurrent diseases including active infections or cardiac arrhythmia
- History of interstitial lung disease or pneumonitis requiring steroids, or current evidence of these
- History of second primary cancer except certain treated cancers with no active disease or treatment in last 2 years
- Infection with HIV or active/chronic hepatitis B or hepatitis C
- Major surgery within 4 weeks before first study dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 12 months
Participants receive the study drug YH42946 to evaluate safety, tolerability, pharmacokinetics, and anti-tumor activity. The treatment includes a dose escalation phase followed by a dose expansion phase with several independent cohorts.
Visits scheduled according to dose escalation and expansion protocols during treatment
Trial Site Locations
Total: 8 locations
1
Next Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
2
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
3
The Catholic Univ. of Korea St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea, 16247
Actively Recruiting
4
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea, 28644
Actively Recruiting
5
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
6
Severance Hospital, Yonsei University
Seoul, South Korea, 03722
Actively Recruiting
7
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
8
Asan Medical Center, University of Ulsan
Seoul, South Korea
Actively Recruiting
Research Team
Y
Yuhan Corporation Clinical Operation Team 1
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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