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
- Adelaide, Melbourne, Perth, and Sydney, AustraliaSee the 4 sites
- Phase
- Phase 1/2
Where in Australia
- Southern Oncology Clinical Research UnitAdelaide, AustraliaNo longer taking part
- Austin HealthMelbourne, AustraliaNo longer taking part
- Breast Cancer Research Centre - WAPerth, AustraliaNo longer taking part
- Blacktown HospitalSydney, AustraliaTaking 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.