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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

137

Participants

Timeline

Start Date

August 26, 2022

Primary Completion Date

October 1, 2026

Study Completion Date

December 1, 2026

Conditions
HER2-Positive Solid Tumor
Interventions
DRUG

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 65 and 40 patients, respectively."

Trial Locations (18)

13496

RECRUITING

CHA Bundang Medical Center, Seongnam-si

16247

NOT_YET_RECRUITING

Catholic University of Korea St. Vincent's Hospital, Suwon

16499

NOT_YET_RECRUITING

Ajou University Hospital, Suwon

21565

NOT_YET_RECRUITING

Gachon Gil University Medical Center, Incheon

37232

NOT_YET_RECRUITING

Vanderbilt Ingram Cancer Center, Nashville

44437

NOT_YET_RECRUITING

Ulsan University Hospital, Ulsan

52727

NOT_YET_RECRUITING

Gyeongsang National University Hospital, Jinju

02215

RECRUITING

Dana Farber Cancer Institute, Boston

Unknown

RECRUITING

Southern Oncology Clinical Research Unit, Adelaide

RECRUITING

Austin Health, Melbourne

WITHDRAWN

Breast Cancer Research Centre - WA, Perth

RECRUITING

Blacktown Hospital, Sydney

02841

RECRUITING

Korea University Anam Hospital, Seoul

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

06591

RECRUITING

The Catholic University of Korea, St. Mary's hospital, Seoul

All Listed Sponsors
lead

Yuhan Corporation

INDUSTRY