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Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
Trial Status: active
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.
Inclusion 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05523947.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Tennessee
Nashville
Vanderbilt University/Ingram Cancer Center
Status: Active
Name Not Available
YH32367, a novel HER2/4-1BB bispecific antibody (BsAb), simultaneously targets HER2 and
h4-1BB and binds to both targets. YH32367 exhibits a strong 4-1BB signal activation as
well as blocking of HER2 signaling in HER2-expressing tumor cells. YH32367 stimulates
IFN-γ secretion from T cells and thereby induces tumor cells lysis.
This is a Phase 1/2, open-label, multicenter, first-in-human study of YH32367. This
2-part study will include both a Dose Escalation part, to identify the Maximum Tolerated
Dose (MTD) and/or two dose levels for RP2D selection, and a Dose Expansion part, to
determine RP2D and to confirm the safety, tolerability and efficacy of YH32367 at the
