RecruitingPhase 1Phase 2NCT05523947

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

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


Sponsor

Yuhan Corporation

Enrollment

147 participants

Start Date

Aug 26, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new drug called YH32367 in patients with HER2-positive cancers (tumors that have too much of a protein called HER2 on their surface) that are locally advanced or have spread to other organs. It includes a specific focus on bile duct cancers and other HER2-positive solid tumors. **You may be eligible if...** - Your tumor has been confirmed to be HER2-positive by pathology testing - For the expansion part: you have at least one measurable tumor on imaging - You have either: HER2-positive bile duct cancer (biliary tract cancer), or a HER2-positive metastatic solid tumor other than breast or stomach cancer - You have provided a tumor tissue sample **You may NOT be eligible if...** - Your brain cancer (CNS metastases) is uncontrolled or you have spinal cord compression - You have heart failure or recent heart attack - You have lung inflammation (interstitial lung disease or pneumonitis) - You have HIV, active hepatitis B or C - You are on long-term steroid therapy or have an autoimmune disease - You have a history of a second primary cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGYH32367

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

View Full Details on ClinicalTrials.gov

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NCT05523947