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

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.

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 approximately 75 and 40 patients, respectively.

Sponsors & Collaborators

• Yuhan Corporation

  lead INDUSTRY

Principal Investigators

• Hyejin Choi · Severance Hospital

• Kyu-pyo Kim · Asan Medical Center

• Do-Youn Oh · Seoul National University Hospital

• Joon Oh Park · Samsung Medical Center

• Ganessan Kichenadasse · Southern Oncology Clinical Research Unit

• Jennifer Man · Blacktown Hospital

• Arlene Chan · Breast Cancer Research Centre WA

• Ju Won Kim · Korea University Anam Hospital

• Myung Ah Lee · The Catholic University of Korea, St. Mary's hospital

• Hongjae Chon · CHA Bundang Medical Center

• Niall Tebbutt · Austin Health

• Jung Hun Kang · Gyeongsang National University Hospital

• Seok Yun Kang · Ajou University School of Medicine

• Hyung Soon Park · Catholic University of Korea St. Vincent's Hospital

• Ji Hong Bae · Gachon Gil University Medical Center

• Cheol Kyung Sin · Ulsan University Hospital

• Hae Seong Park · Dana-Farber Cancer Institute

• Thatcher Heumman · Vanderbilt-Ingram Cancer Center

• Hongsik Kim · Chungbuk National University Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-26

Primary Completion

2028-03-31

Completion

2028-04-30

FDA Drug

Yes

Countries

• United States
• Australia
• South Korea

Study Locations