Treatment with YH32367 for HER2 Positive Advanced Solid Tumors
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
PHASE1; PHASE2 · Yuhan Corporation · NCT05523947
This study is testing a new treatment called YH32367 to see if it can safely help people with advanced solid tumors that are HER2-positive.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 147 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yuhan Corporation (industry) |
| Locations | 19 sites (Boston, Massachusetts and 18 other locations) |
| Trial ID | NCT05523947 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerability, pharmacokinetics, and anti-tumor activity of YH32367, a bispecific antibody targeting HER2 and 4-1BB, in patients with HER2-positive locally advanced or metastatic solid tumors. The study consists of two parts: a Dose Escalation phase to determine the Maximum Tolerated Dose (MTD) and a Dose Expansion phase to confirm the safety and efficacy at the recommended dose. Participants must provide tumor tissue samples and have measurable lesions to qualify for the trial.
Who should consider this trial
Good fit: Ideal candidates include patients with pathologically confirmed HER2-positive locally advanced or metastatic solid tumors.
Not a fit: Patients with uncontrolled CNS metastases, certain heart conditions, or autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HER2-positive solid tumors.
How similar studies have performed: Other studies involving bispecific antibodies targeting HER2 have shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts and 18 other locations
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
- Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States (RECRUITING)
- Southern Oncology Clinical Research Unit — Adelaide, Australia (RECRUITING)
- Austin Health — Melbourne, Australia (RECRUITING)
- Breast Cancer Research Centre - WA — Perth, Australia (WITHDRAWN)
- Blacktown Hospital — Sydney, Australia (RECRUITING)
- CHA Bundang Medical Center — Seongnam-si, Gyeonggi-do, South Korea (RECRUITING)
- Catholic University of Korea St. Vincent's Hospital — Suwon, Gyeonggi-do, South Korea (RECRUITING)
- Ajou University Hospital — Suwon, Gyeonggi-do, South Korea (RECRUITING)
- Gyeongsang National University Hospital — Jinju, Gyeongsangnam-do, South Korea (RECRUITING)
- Chungbuk National University Hospital — Cheongju-si, North Chungcheong, South Korea (RECRUITING)
- Gachon Gil University Medical Center — Incheon, South Korea (RECRUITING)
- Korea University Anam Hospital — Seoul, South Korea (RECRUITING)
- Seoul National University Hospital — Seoul, South Korea (RECRUITING)
- Severance Hospital, Yonsei University Health System — Seoul, South Korea (RECRUITING)
- Asan Medical Center — Seoul, South Korea (RECRUITING)
- Samsung Medical Center — Seoul, South Korea (RECRUITING)
- The Catholic University of Korea, St. Mary's hospital — Seoul, South Korea (RECRUITING)
- Ulsan University Hospital — Ulsan, South Korea (RECRUITING)
Study contacts
- Principal investigator: Hyejin Choi — Severance Hospital
- Study coordinator: Clinical Operation Team 1
- Email: clinicaltrials@yuhan.co.kr
- Phone: +82-2-828-0858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HER2-Positive Solid Tumor, YH32367, HER2/4-1BB bispecific antibody, Solid tumor, Breast cancer, Gastric cancer, HER2-positive, Biliary tract cancer