Tests YH32367 in adults with HER2-positive solid tumors that have spread
Tests the new drug YH32367 in adults with HER2-positive solid tumors that are advanced.
Plain-language title generated from the registry record
Registry title: Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
Key facts
- Where
- Cheongju-si, Incheon, Jinju, Seongnam-si, Seoul, Suwon, and Ulsan, South KoreaSee the 13 sites
- Phase
- Phase 1/2
Where in South Korea
- Chungbuk National University HospitalCheongju-si, South KoreaTaking people
- Gachon Gil University Medical CenterIncheon, South KoreaTaking people
- Gyeongsang National University HospitalJinju, South KoreaTaking people
- CHA Bundang Medical CenterSeongnam-si, South KoreaTaking people
- Asan Medical CenterSeoul, South KoreaTaking people
- Korea University Anam HospitalSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaTaking people
- Severance Hospital, Yonsei University Health SystemSeoul, South KoreaTaking people
- The Catholic University of Korea, St. Mary's HospitalSeoul, South KoreaTaking people
- Ajou University HospitalSuwon, South KoreaTaking people
- Catholic University of Korea St. Vincent's HospitalSuwon, South KoreaTaking people
- Ulsan University HospitalUlsan, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yuhan Corporation
- Trial code
- NCT05523947
- Record updated
- 24 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: [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: Systemic steroid therapy; 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; Uncontrolled central nervous system (CNS) metastases; Spinal cord compression; Carcinomatous meningitis.