Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
Recruiting · NCT05523947 · Interventional (participants receive a specific treatment) · Lead sponsor: Yuhan Corporation
View the official record on ClinicalTrials.gov →Interventions studied
YH32367
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion 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
Exclusion criteria
- 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
Where it is running
19 locations listed across 2 US states.
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Vanderbilt Ingram Cancer Center - Nashville, Tennessee, United States
- Southern Oncology Clinical Research Unit - Adelaide, Australia
- Gachon Gil University Medical Center - Incheon, South Korea
- Austin Health - Melbourne, Australia
- Breast Cancer Research Centre - WA - Perth, Australia
- Korea University Anam Hospital - Seoul, South Korea
- Seoul National University Hospital - Seoul, South Korea
- Severance Hospital, Yonsei University Health System - Seoul, South Korea
- Asan Medical Center - Seoul, South Korea
- Samsung Medical Center - Seoul, South Korea
- The Catholic University of Korea, St. Mary's hospital - Seoul, South Korea
- Blacktown Hospital - Sydney, Australia
- Ulsan University Hospital - Ulsan, South Korea
- CHA Bundang Medical Center - Seongnam-si, Gyeonggi-do, South Korea
- Catholic University of Korea St. Vincent's Hospital - Suwon, Gyeonggi-do, South Korea
- Ajou University Hospital - Suwon, Gyeonggi-do, South Korea
- Gyeongsang National University Hospital - Jinju, Gyeongsangnam-do, South Korea
- Chungbuk National University Hospital - Cheongju-si, North Chungcheong, South Korea