NCT06975410 Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors
| NCT ID | NCT06975410 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Yuhan Corporation |
| Condition | EGFR Overexpression |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-06-12 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2025-06-12 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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 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
Contact & Investigator
Yuhan Clinical Research Physician
STUDY DIRECTOR
Yuhan Corporation
Frequently Asked Questions
Who can join the NCT06975410 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying EGFR Overexpression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06975410 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06975410 currently recruiting?
Yes, NCT06975410 is actively recruiting participants. Contact the research team at clinicaltrials@yuhan.co.kr for enrollment information.
Where is the NCT06975410 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06975410 clinical trial?
NCT06975410 is sponsored by Yuhan Corporation. The principal investigator is Yuhan Clinical Research Physician at Yuhan Corporation. The trial plans to enroll 80 participants.