Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor

Recruiting now · Phase 1/Phase 2

Conditions studied: HER2-Positive Solid Tumor

In brief

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.

Key facts

Study ID

NCT05523947

Run by

Yuhan Corporation

People needed

147

Starts

2022-08-26

Expected to finish

2028-04-30

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• [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

You may not qualify if…

• 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

• Ulsan University Hospital — Ulsan, South Korea (enrolling)
• Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)
• The Catholic University of Korea, St. Mary's hospital — Seoul, South Korea (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Blacktown Hospital — Sydney, Australia (enrolling)
• CHA Bundang Medical Center — Seongnam-si, Gyeonggi-do, South Korea (enrolling)
• Catholic University of Korea St. Vincent's Hospital — Suwon, Gyeonggi-do, South Korea (enrolling)
• Ajou University Hospital — Suwon, Gyeonggi-do, South Korea (enrolling)
• Gyeongsang National University Hospital — Jinju, Gyeongsangnam-do, South Korea (enrolling)
• Chungbuk National University Hospital — Cheongju-si, North Chungcheong, South Korea (enrolling)
• Gachon Gil University Medical Center — Incheon, South Korea (enrolling)
• Korea University Anam Hospital — Seoul, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Severance Hospital, Yonsei University Health System — Seoul, South Korea (enrolling)
• Asan Medical Center — Seoul, South Korea (enrolling)
• Southern Oncology Clinical Research Unit — Adelaide, Australia
• Austin Health — Melbourne, Australia
• Breast Cancer Research Centre - WA — Perth, Australia

Full record on ClinicalTrials.gov

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