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
- HER2-Positive Solid Tumor
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Yuhan Corporation
- Enrolment target
- 147
- Started
- 26 August 2022
- Main results due
- 31 March 2028
- Study sites
- 19
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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 1. Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer 2. 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(19)
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Withdrawn
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Recruiting
Southern Oncology Clinical Research Unit
Adelaide, Australia
Terminated
Austin Health
Melbourne, Australia
Withdrawn
Breast Cancer Research Centre - WA
Perth, Australia
Withdrawn
Blacktown Hospital
Sydney, Australia
Recruiting
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Recruiting
Catholic University of Korea St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Recruiting
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Recruiting
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Recruiting
Gachon Gil University Medical Center
Incheon, South Korea
Recruiting
Korea University Anam Hospital
Seoul, South Korea
Recruiting
Seoul National University Hospital
Seoul, South Korea
Recruiting
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Recruiting
Asan Medical Center
Seoul, South Korea
Recruiting
Samsung Medical Center
Seoul, South Korea
Recruiting
The Catholic University of Korea, St. Mary's hospital
Seoul, South Korea
Recruiting
Ulsan University Hospital
Ulsan, South Korea
Recruiting
Showing 19 of 19 sites. 15 of the 19 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05523947. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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