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

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