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

Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors (NCT06975410) is a Phase 1 / Phase 2 interventional studying EGFR Overexpression and Locally Advanced Solid Tumor, sponsored by Yuhan Corporation. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For EGFR Overexpression, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 80 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused EGFR Overexpression subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Must sign an willing to sign a consent form form (ICF) prior to any study specific procedures - You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1 - Estimated expected to live 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. Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

YH32364

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)

Locations (4)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06975410), the sponsor (Yuhan Corporation), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06975410 clinical trial studying?

Who can participate in NCT06975410?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06975410?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06975410. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06975410. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.