NCT05523947RecruitingPhase 1/2
Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
A Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32367 in Patients With HER2-Positive Locally Advanced or Metastatic Solid Tumors
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 147 (estimated)
- First submitted
- 24 Aug 2022
- Start date
- 26 Aug 2022
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Yuhan Corporation
- NCT number
- NCT05523947
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 147
- From 26 Aug 2022 to the primary completion date, 31 Mar 2028
- 19 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Systemic steroid therapy
Other illness
- 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
- Autoimmune disease
Other
- Uncontrolled central nervous system (CNS) metastases
- Spinal cord compression
- Carcinomatous meningitis
Who the study is looking for
- \[Dose Escalation Part\]
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Southern Oncology Clinical Research Unit Coordinator of this site? Confirm its status | Adelaide | Australia | Terminated |
| Austin Health Coordinator of this site? Confirm its status | Melbourne | Australia | Withdrawn |
| Breast Cancer Research Centre - WA Coordinator of this site? Confirm its status | Perth | Australia | Withdrawn |
| Blacktown Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Recruiting |
| Gachon Gil University Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Gyeongsang National University Hospital Coordinator of this site? Confirm its status | Jinju | South Korea | Recruiting |
| CHA Bundang Medical Center Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea, St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
| Catholic University of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Withdrawn |
| Vanderbilt-Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.