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

National Clinical Trial ID:: NCT05523947(opens in a new tab)
Protocol ID:: VICC-DTMDT24023
Primary Investigator:: Thatcher Heumann
Phase:: I/II
Age Group:: Adults
Genders Eligible:: All
Drug:: YH32367
Cancer Type:: Miscellaneous

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.

Detailed 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.

Who Can Participate

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

Disclaimer

This summary is based on publicly available information from clinicaltrials.gov and is intended to help patients discuss possible trial options with their oncology care team. ClinicalTrials.gov and related public listings do not independently review or approve the safety and scientific merit of every study.

Participation decisions can be made only after review by the study team and your treating clinician.