Overview
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.
Description
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 RP2D.
Eligibility
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
- Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer
- 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