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Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
Sponsor: Yuhan Corporation
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
147
Start Date
2022-08-26
Completion Date
2028-04-30
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
YH32367
Dose Escalation Part: 8 Cohorts. In this part, approximately 30 patients will be enrolled and patients are assigned to receive YH32367 at a starting dose and the dose being escalated/de-escalated in adjacent dose cohorts will be up to Dose level 8. Dose Expansion Part: 2 Cohorts(Cohort 1: Biliary tract cancer, Cohort 2: Solid tumors). The part will consist of multiple cohorts in patients who were treated with at least 1 prior gemcitabine- and/or cisplatin-based therapy, HER2 positive biliary tract cancer(Cohort 1); in patients who were treated with all available standard therapies and have no available options, HER2 positive solid tumor malignancies other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer(Cohort 2). Each cohort will enroll approximately 75 and 40 patients, respectively.
Locations (19)
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Southern Oncology Clinical Research Unit
Adelaide, Australia
Austin Health
Melbourne, Australia
Breast Cancer Research Centre - WA
Perth, Australia
Blacktown Hospital
Sydney, Australia
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Catholic University of Korea St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Gachon Gil University Medical Center
Incheon, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea, St. Mary's hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea