Actively Recruiting
Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors
Led by Yuhan Corporation · Updated on 2025-08-01
80
Participants Needed
4
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a study for people with locally advanced or metastatic cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with Epidermal Growth Factor Receptor (EGFR) overexpressing can join the study. The purpose of this study is to find out whether a medicine called YH32364 helps people with locally advanced or metastatic cancers with EGFR overexpression.
CONDITIONS
Official Title
Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must sign an informed consent form before any study procedures
- Have an ECOG performance status of 0 or 1
- Estimated life expectancy of at least 3 months
- Women must not be breastfeeding
- Have at least one measurable tumor lesion that has not been previously irradiated or biopsied during screening, measuring at least 10 mm in longest diameter (or 15 mm short axis for lymph nodes) on CT or MRI
- For Dose Escalation: Have locally advanced or metastatic EGFR overexpressing solid tumor that is refractory or intolerable to all standard therapies and not curable by local treatments
- Tumor types for Dose Escalation include pathologically confirmed EGFR overexpressing head and neck squamous cell carcinoma, non-small cell lung cancer (squamous cell), esophageal squamous cell carcinoma, biliary tract cancer, uterine cervical cancer, vulvar cancer, urothelial cancer, or squamous cell carcinoma of other origins
- For Dose Expansion Cohort 1: Have pathologically confirmed EGFR overexpressing locally advanced or metastatic head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) refractory or intolerable to all standard treatments and not curable by local therapy
You will not qualify if you...
- Have uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis
- History of a second primary cancer except for cured non-melanoma skin cancer, cured cervical or breast carcinoma in situ, or other cancers with no active disease and no treatment in last 2 years
- History of or current Class II, III, or IV heart failure
- History of acute coronary syndromes or related heart procedures within past 24 weeks
- History of interstitial lung disease or pneumonitis requiring steroids, or current evidence of these conditions
- Have autoimmune disease requiring systemic treatment
- Infection with HIV
- Active chronic hepatitis B or C
- Have received systemic steroid therapy
- Prior treatment with 4-1BB/CD137-modulating agents
- Use of live vaccines within 4 weeks
- Previous immunotherapy, biological therapies, targeted small molecules, hormonal therapies, radiation therapy, or cytotoxic chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
2
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
3
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
4
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
C
Clinical Operation Team 1
CONTACT
Y
Yunhaeng Heo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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