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New treatment option for EGFR Overexpression
Official title Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors
ClinicalTrials.gov ID: NCT06975410
What this study is testing
What is YH32364?
YH32364 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for egfr overexpression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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)
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.