BridgeMD
New treatment option for HER2-Positive Solid Tumor
Official title Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
ClinicalTrials.gov ID: NCT05523947
What this study is testing
What is YH32367?
YH32367 is an investigational medicine, being studied as a potential treatment for her2-positive solid tumor.
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 first-in-human study will be counducted to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of YH32367 in Patients with HER2-Positive Locally Advanced or Metastatic Solid Tumors.
- 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
- [Dose Escalation Part]
- Pathologically confirmed HER2-positive
- Mandatory provision of tumor tissue sample [Dose Expansion Part]
- Patients who have at least one measurable lesion
- Mandatory provision of tumor tissue sample
You likely can't join if
- Uncontrolled central nervous system (CNS) metastases
- Spinal cord compression
- Carcinomatous meningitis
- Acute coronary syndromes
- Heart failure
- Interstitial lung disease (ILD)
See the full eligibility criteria
- [Dose Escalation Part]
- Pathologically confirmed HER2-positive
- Mandatory provision of tumor tissue sample [Dose Expansion Part]
- Patients who have at least one measurable lesion
- Mandatory provision of tumor tissue sample
- Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer
- Cohort 2: Pathologically confirmed HER2-positive metastatic solid tumor malignancy other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer
- Uncontrolled central nervous system (CNS) metastases
- Spinal cord compression
- Carcinomatous meningitis
- Acute coronary syndromes
- Heart failure
- Interstitial lung disease (ILD)
- Pneumonitis
- History of a second primary cancer
- Human immunodeficiency virus (HIV)
- Active chronic hepatitis B
- Hepatitis C
- Systemic steroid therapy
- Autoimmune disease
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Nashville, Tennessee, United States
- Adelaide, Australia
- Melbourne, Australia
- Perth, Australia
- Sydney, Australia
- Seongnam-si, Gyeonggi-do, South Korea
- Suwon, Gyeonggi-do, South Korea
- Jinju, Gyeongsangnam-do, South Korea
- Cheongju-si, North Chungcheong, South Korea
- Incheon, South Korea
- Seoul, South Korea
- Ulsan, 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 Boston, Massachusetts, United States; Nashville, Tennessee, United States; Adelaide, Australia; Melbourne, Australia; Perth, Australia; Sydney, Australia and 7 more location(s). 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.