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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: \[Dose Escalation Part\] - Pathologically confirmed HER2-positive - Mandatory provision of tumor tissue sample \[Dose Expansion Part\] - Patients who have at least one measurable lesion - Mandatory provision of tumor tissue sample 1. Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer 2. Cohort 2: Pathologically confirmed HER2-positive metastatic solid tumor malignancy other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer Who Should NOT Join This Trial: - Uncontrolled central nervous system (CNS) metastases - Spinal cord compression - Carcinomatous meningitis - Acute coronary syndromes - Heart failure - Interstitial lung disease (ILD) - Pneumonitis - History of a second primary cancer - Human weakened immune system virus (HIV) - Active chronic hepatitis B - Hepatitis C - Systemic steroid therapy - autoimmune conditions (where your immune system attacks your own body) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: \[Dose Escalation Part\] * Pathologically confirmed HER2-positive * Mandatory provision of tumor tissue sample \[Dose Expansion Part\] * Patients who have at least one measurable lesion * Mandatory provision of tumor tissue sample 1. Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer 2. Cohort 2: Pathologically confirmed HER2-positive metastatic solid tumor malignancy other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer Exclusion Criteria: * Uncontrolled central nervous system (CNS) metastases * Spinal cord compression * Carcinomatous meningitis * Acute coronary syndromes * Heart failure * Interstitial lung disease (ILD) * Pneumonitis * History of a second primary cancer * Human immunodeficiency virus (HIV) * Active chronic hepatitis B * Hepatitis C * Systemic steroid therapy * Autoimmune disease

Treatments Being Tested

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.

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