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
1 other identifier
interventional
80
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2025
Longer than P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2025
CompletedFirst Posted
Study publicly available on registry
May 16, 2025
CompletedStudy Start
First participant enrolled
June 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
August 1, 2025
July 1, 2025
2 years
April 28, 2025
July 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Treatment-emergent adverse events (TEAEs) including dose limiting toxicities (DLTs)
To assess the safety and tolerability of YH32364 in order to determine maximum tolerated dose (MTD) and select doses for dose optimization
Study Day 1 to Study Day 28 (during the DLTs evaluation period)
Objective Response Rate (ORR)
To assess the ORR of YH32364 at the recommended dose (RD) according to RECIST v1.1 by Investigator assessment
through dose expansion part completion, approximately 1.5 year
Secondary Outcomes (23)
Area under the serum concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
through study completion, approximately 2.5 year
AUC from time 0 to infinity (AUCinf)
through study completion, approximately 2.5 year
Maximum observed serum concentration (Cmax)
through study completion, approximately 2.5 year
Time to reach Cmax (Tmax)
through study completion, approximately 2.5 year
Apparent terminal elimination half-life (t1/2)
through study completion, approximately 2.5 year
- +18 more secondary outcomes
Other Outcomes (3)
Immune ORR (iORR)
through study completion, approximately 2.5 year
Immune Duration of Response (iDOR)
through study completion, approximately 2.5 year
Immune PFS (iPFS)
through study completion, approximately 2.5 year
Study Arms (1)
YH32364
EXPERIMENTALDose Escalation Part: Dose Escalation part is designed to assess the safety and tolerability of YH32364 and to identify the Maximum Tolerated dose (MTD) and/or two dose levels for recommended dose (RD) selection. Dose Expansion Part: Dose Expansion part will consist of multiple cohorts by cancer types. Cohort 1 will be initiated to determine the RD after completion of Part 1. The RD will be determined among two dose levels investigated in Cohort 1 based on the totality of available data including PK, biomarkers, dose-response, safety, and efficacy.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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)
- +1 more criteria
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yuhan Clinical Research Physician
Yuhan Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2025
First Posted
May 16, 2025
Study Start
June 12, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2029
Last Updated
August 1, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Beginning 1 year and ending 5 years after all trial endpoints were assessed
- Access Criteria
- Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to clinicaltrials@yuhan.co.kr
De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to clinicaltrials@yuhan.co.kr A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov) no later than 1 year after the study's primary completion date.