Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors

Launched by YUHAN CORPORATION · May 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called YH32364 to see if it can help adults with advanced cancers that have a specific feature known as EGFR overexpression. This means the cancer cells have too much of a certain protein that can make them grow. The trial is for patients aged 18 and older whose cancer has not improved with other treatments. To participate, patients must have at least one measurable tumor and a life expectancy of at least three months. They also need to sign a consent form agreeing to be part of the study.

The trial is currently not recruiting participants, but if you or a loved one are considering joining when it starts, you should know that the study will involve regular check-ups and monitoring to assess the effectiveness of the treatment. Some patients may not be eligible if they have certain health conditions, like uncontrolled brain metastases or specific heart issues. Overall, the aim of this trial is to explore whether YH32364 can provide a new treatment option for those battling these difficult-to-treat cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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