Status:
RECRUITING
Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors
Lead Sponsor:
Yuhan Corporation
Conditions:
EGFR Overexpression
Locally Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
YH32364 is a new type of immunotherapy called a bispecific antibody that targets both Epidermal Growth Factor Receptor (EGFR) and 4-1BB. EGFR is a gene involved in cancer growth, and many cancer treat...
Eligibility Criteria
Inclusion
- Must sign an informed consent form (ICF) prior to any study specific procedures
- ECOG performance status 0 or 1
- Estimated life expectancy of at least 3 months
- A woman must not be breastfeeding
- Have at least one measurable lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline ≥10 mm in the longest diameter (except lymph nodes which must have a short axis of ≥15 mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), are suitable for accurate repeated measurements.
- \[Dose Escalation Only\] Locally advanced or metastatic EGFR overexpressing solid tumor\* that is refractory or intolerable on all available standard therapy and that is considered uncurable by local therapy
- \* One of the following pathologically confirmed EGFR overexpressing (IHC3+ or IHC2+) tumors.
- Head and neck squamous cell carcinoma (HNSCC)
- Non-small cell lung cancer (NSCLC): squamous cell carcinoma (SqCC)
- Esophageal squamous cell carcinoma (ESCC)
- Biliary tract cancer (BTC)
- Uterine cervical cancer
- Vulvar cancer
- Urothelial cancer
- Squamous cell carcinoma of other origin of tumor (e.g., skin squamous cell tumor)
- \[Dose Expansion Only\] Cohort 1: Pathologically confirmed EGFR overexpressing (IHC3+ or IHC2+), locally advanced or metastatic HNSCC other than nasopharyngeal carcinoma (NPC)\* that is refractory or intolerable on all available standard therapy and that is considered uncurable by local therapy.
Exclusion
- Known uncontrolled central nervous system (CNS) metastases, spinal cord compression, and/or carcinomatous meningitis
- Have history of a second primary cancer with the exception of
- curatively treated non-melanomatous skin cancer
- curatively treated cervical or breast carcinoma in situ, or
- other malignancy with no known active disease present and no treatment administered during the last 2 years
- Have history of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA)
- Have history of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks
- Have history of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or any evidence of current ILD or pneumonitis
- Have autoimmune disease that has required systemic treatment
- Infection with human immunodeficiency virus (HIV)
- Active chronic hepatitis B or chronic hepatitis C
- \[Prior/Concomitant Therapy\]
- Have received systemic steroid therapy
- Previous treatment with a 4-1BB/CD137-modulating agent
- Have used a live vaccine within 4 weeks
- Have received treatment with immunotherapy, biological therapies, targeted small molecules, or hormonal therapies
- Have received radiation therapy
- Have received cytotoxic chemotherapy
Key Trial Info
Start Date :
June 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06975410
Start Date
June 12 2025
End Date
December 1 2029
Last Update
August 1 2025
Active Locations (4)
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1
Korea University Anam Hospital
Seoul, South Korea, 02841
2
Seoul National University Hospital
Seoul, South Korea, 03080
3
Severance Hospital
Seoul, South Korea, 03722
4
Samsung Medical Center
Seoul, South Korea, 06351