Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Sol… (NCT06975410) | Clinical Trial Compass
RecruitingPhase 1/2
Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors
South Korea80 participantsStarted 2025-06-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1/Phase 2 trial testing YH32364 in humans for the first time at various dose levels, what is currently known about its safety profile, and what kinds of side effects or dose-limiting toxicities have been seen so far?
2My tumor needs to show EGFR overexpression to be considered for this trial — can you tell me whether my pathology results confirm that, and how that would be tested or confirmed if not already done?
3Because this is an early-phase trial focused partly on finding the right dose, how does that affect the balance between potential benefit and unknown risks for someone in my situation compared to standard treatment options that already exist?
4If I join this trial and experience a serious treatment-emergent adverse event, what would the process look like for adjusting or stopping treatment, and how would my care be managed?
5Given that this trial is still recruiting and working through dose escalation, would it make more sense for me to try an established therapy first, and could I still be eligible for this trial later if needed?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment-emergent adverse events (TEAEs) including dose limiting toxicities (DLTs)
Timeframe: Study Day 1 to Study Day 28 (during the DLTs evaluation period)
2
Objective Response Rate (ORR)
Timeframe: through dose expansion part completion, approximately 1.5 year