RecruitingPhase 1Phase 2NCT06975410

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

A Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32364 in Patients With Locally Advanced or Metastatic Solid Tumors

Sponsor

Yuhan Corporation

Enrollment

80 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Solid Tumor Locally Advanced Solid Tumor EGFR Overexpression

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 (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.

Eligibility

Min Age: 18 Years

Inclusion Criteria16

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 Criteria18

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

Interventions

DRUGYH32364

Dose Escalation Part: In this part, 6 dose levels are planned and approximately 30 patients will be enrolled. After each dose level, Safety Review Committee (SRC) will evaluate the available safety, tolerability, PK of YH32364 to decide the next dose. Dose Expansion Part: 50 participants with previously treated locally advanced or metastatic EGFR overexpressing HNSCC other than NPC will be randomized 1:1 ratio to each dose. (Cohort 1: Participants with locally advanced or metastatic EGFR overexpressing HNSCC other than NPC, whose disease progressed after or who are intolerable to all the available standard treatment)