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

Last updated: March 30, 2025
Sponsor: Yuhan Corporation
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

YH32367

Clinical Study ID

NCT05523947
YH32367-101
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 tumormalignancy other than breast and gastric or gastroesophageal junctionadenocarcinoma and biliary tract cancer

Exclusion

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 Design

Total Participants: 137
Treatment Group(s): 1
Primary Treatment: YH32367
Phase: 1/2
Study Start date:
August 26, 2022
Estimated Completion Date:
December 01, 2026

Study 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.

Connect with a study center

  • Southern Oncology Clinical Research Unit

    Adelaide,
    Australia

    Active - Recruiting

  • Austin Health

    Melbourne,
    Australia

    Active - Recruiting

  • Breast Cancer Research Centre - WA

    Perth,
    Australia

    Site Not Available

  • Blacktown Hospital

    Sydney,
    Australia

    Active - Recruiting

  • CHA Bundang Medical Center

    Seongnam, Gyeonggi-do 13496
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, St. Mary's hospital

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

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