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

Sponsor: Yuhan Corporation

Sponsor score: 40

ClinicalTrials ID:NCT05523947

This Phase 1/2 study evaluates YH32367, a HER2/4-1BB bispecific antibody, for safety, tolerability, and efficacy in HER2-positive tumors. It includes dose escalation to find the MTD and dose expansion for further assessment. Eligibility requires HER2-positive status and tumor samples. Interventions involve escalating doses in 8 cohorts and expansion in 2 cohorts for specific cancers.

Patient Parameters

Program 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 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

Locations

FACILITYZIPCITYSTATE
Dana Farber Cancer Institute02215BostonMassachusetts
Vanderbilt Ingram Cancer Center37232NashvilleTennessee

Get This Program In Your Inbox

You can sign up and apply your patients for this program.