Actively Recruiting
A Phase 1/2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946
Led by Yuhan Corporation · Updated on 2025-11-04
161
Participants Needed
8
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 of 0 or 1
- Life expectancy of at least 3 months
- Patients progressed on or after all available standard therapies or for whom standard treatment is not appropriate
- Must provide archived or fresh tumor tissue to confirm HER2 or EGFR mutation
- History of brain metastases only if all lesions have been treated
- Adequate bone marrow function (neutrophils ≥1.5 x10^9 cells/L without recent G-CSF, platelets ≥75 x10^9 cells/L, hemoglobin ≥9 g/dL without recent transfusion)
- Adequate liver function (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/1.73 m^2)
- For dose escalation: confirmed diagnosis of advanced or metastatic non-hematologic cancer with documented HER2 or EGFR mutation
- For dose expansion: confirmed locally advanced or metastatic NSCLC with HER2 exon 20 insertion (Cohort 1)
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 Class II, III, or IV heart failure
- Medical, psychiatric, cognitive, or other conditions preventing informed consent or study compliance
- Severe concurrent diseases including active infections or cardiac arrhythmia judged inappropriate for participation
- History of interstitial lung disease or pneumonitis requiring steroids or current evidence of these conditions
- History of second primary cancer except curatively treated non-melanomatous skin cancer, cervical or breast carcinoma in situ, or other malignancy with no active disease or treatment in last 2 years
- Infection with HIV or prior or active hepatitis B or active hepatitis C
- Major surgery within 4 weeks prior to first study dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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