RECRUITING

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

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Conditions

HER2-Positive Solid TumorYH32367HER2/4-1BB bispecific antibodySolid tumorBreast cancerGastric cancerHER2-positiveBiliary tract cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-08-26
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05523947

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically confirmed HER2-positive
  2. * Mandatory provision of tumor tissue sample
  3. * Patients who have at least one measurable lesion
  4. * Mandatory provision of tumor tissue sample
  5. 1. Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer
  6. 2. Cohort 2: Pathologically confirmed HER2-positive metastatic solid tumor malignancy other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer
  1. * Uncontrolled central nervous system (CNS) metastases
  2. * Spinal cord compression
  3. * Carcinomatous meningitis
  4. * Acute coronary syndromes
  5. * Heart failure
  6. * Interstitial lung disease (ILD)
  7. * Pneumonitis
  8. * History of a second primary cancer
  9. * Human immunodeficiency virus (HIV)
  10. * Active chronic hepatitis B
  11. * Hepatitis C
  12. * Systemic steroid therapy
  13. * Autoimmune disease

Contacts and Locations

Study Contact

Clinical Operation Team 1
CONTACT
+82-2-828-0858
clinicaltrials@yuhan.co.kr
Jiyong Park
CONTACT
+82-2-828-0858
pjy0422@yuhan.co.kr

Principal Investigator

Sun Young Rha
PRINCIPAL_INVESTIGATOR
Severance Hospital
Sung-Bae Kim
PRINCIPAL_INVESTIGATOR
Asan Medical Center
Do-Youn Oh
PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Joon Oh Park
PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Ganessan Kichenadasse
PRINCIPAL_INVESTIGATOR
Southern Oncology Clinical Research Unit
Jennifer Man
PRINCIPAL_INVESTIGATOR
Blacktown Hospital
Arlene Chan
PRINCIPAL_INVESTIGATOR
Breast Cancer Research Centre WA
Ju Won Kim
PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Myung Ah Lee
PRINCIPAL_INVESTIGATOR
The Catholic University of Korea, St. Mary's hospital
Hongjae Chon
PRINCIPAL_INVESTIGATOR
CHA Bundang Medical Center
Niall Tebbutt
PRINCIPAL_INVESTIGATOR
Austin Health
Jung Hun Kang
PRINCIPAL_INVESTIGATOR
Gyeongsang National University Hospital
Seok Yun Kang
PRINCIPAL_INVESTIGATOR
Ajou University School of Medicine
Hyung Soon Park
PRINCIPAL_INVESTIGATOR
Catholic University of Korea St. Vincent's Hospital
Ji Hong Bae
PRINCIPAL_INVESTIGATOR
Gachon Gil University Medical Center
Cheol Kyung Sin
PRINCIPAL_INVESTIGATOR
Ulsan University Hospital
Hae Seong Park
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Thatcher Heumman
PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center

Study Locations (Sites)

Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Yuhan Corporation

  • Sun Young Rha, PRINCIPAL_INVESTIGATOR, Severance Hospital
  • Sung-Bae Kim, PRINCIPAL_INVESTIGATOR, Asan Medical Center
  • Do-Youn Oh, PRINCIPAL_INVESTIGATOR, Seoul National University Hospital
  • Joon Oh Park, PRINCIPAL_INVESTIGATOR, Samsung Medical Center
  • Ganessan Kichenadasse, PRINCIPAL_INVESTIGATOR, Southern Oncology Clinical Research Unit
  • Jennifer Man, PRINCIPAL_INVESTIGATOR, Blacktown Hospital
  • Arlene Chan, PRINCIPAL_INVESTIGATOR, Breast Cancer Research Centre WA
  • Ju Won Kim, PRINCIPAL_INVESTIGATOR, Korea University Anam Hospital
  • Myung Ah Lee, PRINCIPAL_INVESTIGATOR, The Catholic University of Korea, St. Mary's hospital
  • Hongjae Chon, PRINCIPAL_INVESTIGATOR, CHA Bundang Medical Center
  • Niall Tebbutt, PRINCIPAL_INVESTIGATOR, Austin Health
  • Jung Hun Kang, PRINCIPAL_INVESTIGATOR, Gyeongsang National University Hospital
  • Seok Yun Kang, PRINCIPAL_INVESTIGATOR, Ajou University School of Medicine
  • Hyung Soon Park, PRINCIPAL_INVESTIGATOR, Catholic University of Korea St. Vincent's Hospital
  • Ji Hong Bae, PRINCIPAL_INVESTIGATOR, Gachon Gil University Medical Center
  • Cheol Kyung Sin, PRINCIPAL_INVESTIGATOR, Ulsan University Hospital
  • Hae Seong Park, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute
  • Thatcher Heumman, PRINCIPAL_INVESTIGATOR, Vanderbilt-Ingram Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-26
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2022-08-26
Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

  • YH32367
  • HER2/4-1BB bispecific antibody
  • Solid tumor
  • Breast cancer
  • Gastric cancer
  • HER2-positive
  • Biliary tract cancer

Additional Relevant MeSH Terms

  • HER2-Positive Solid Tumor