Study of YH32367 for HER2-Positive Advanced Solid Tumors

This study is testing a new drug called YH32367 in people with HER2-positive locally advanced or metastatic (spread to other parts of the body) solid tumors. YH32367 is a bispecific antibody, meaning it targets two things: HER2 (a protein found on some cancer cells) and 4-1BB (a protein on immune cells). The goal is to see how safe YH32367 is, how well your body handles it, and if it can shrink tumors. To join, you must be at least 18 years old and have HER2-positive cancer. The study is currently recruiting about 147 participants, but its overall status is unclear.

Study design
This is a Phase 1/2, open-label (meaning both you and your doctor will know what treatment you are receiving), multicenter study. It will involve about 147 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for at least 21 days after treatment in the dose escalation part. Tumor response will be measured for approximately 2.5 years through the dose expansion part.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05523947

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Yuhan Corporation
~147 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:YH32367

At a glance

Recruiting sites
16 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment-emergent adverse events (TEAEs) up to Day 21
Measured over in dose escalation part, an average of 21 days
+1 more outcome measured
HER2-Positive Solid Tumor
19 sites across 7 states
South Korea8
Australia4
Gyeonggi-do3
Massachusetts1
Tennessee1
Gyeongsangnam-do1
North Chungcheong1
  • Hyejin Choi · PRINCIPAL_INVESTIGATOR · Severance Hospital
  • Kyu-pyo Kim · PRINCIPAL_INVESTIGATOR · Asan Medical Center
  • Do-Youn Oh · PRINCIPAL_INVESTIGATOR · Seoul National University Hospital
  • Joon Oh Park · PRINCIPAL_INVESTIGATOR · Samsung Medical Center
  • Ganessan Kichenadasse · PRINCIPAL_INVESTIGATOR · Southern Oncology Clinical Research Unit
  • Jennifer Man · PRINCIPAL_INVESTIGATOR · Blacktown Hospital
  • Arlene Chan · PRINCIPAL_INVESTIGATOR · Breast Cancer Research Centre WA
  • Ju Won Kim · PRINCIPAL_INVESTIGATOR · Korea University Anam Hospital
  • Myung Ah Lee · PRINCIPAL_INVESTIGATOR · The Catholic University of Korea, St. Mary's hospital
  • Hongjae Chon · PRINCIPAL_INVESTIGATOR · CHA Bundang Medical Center
  • Niall Tebbutt · PRINCIPAL_INVESTIGATOR · Austin Health
  • Jung Hun Kang · PRINCIPAL_INVESTIGATOR · Gyeongsang National University Hospital
  • Seok Yun Kang · PRINCIPAL_INVESTIGATOR · Ajou University School of Medicine
  • Hyung Soon Park · PRINCIPAL_INVESTIGATOR · Catholic University of Korea St. Vincent's Hospital
  • Ji Hong Bae · PRINCIPAL_INVESTIGATOR · Gachon Gil University Medical Center
  • Cheol Kyung Sin · PRINCIPAL_INVESTIGATOR · Ulsan University Hospital
  • Hae Seong Park · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
  • Thatcher Heumman · PRINCIPAL_INVESTIGATOR · Vanderbilt-Ingram Cancer Center
  • Hongsik Kim · PRINCIPAL_INVESTIGATOR · Chungbuk National University Hospital

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Eligibility criteria

Inclusion

Pathologically confirmed HER2-positive
Mandatory provision of tumor tissue sample
Patients who have at least one measurable lesion
Mandatory provision of tumor tissue sample

Exclusion

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
  • Treatment-emergent adverse events (TEAEs) up to Day 21in dose escalation part, an average of 21 days

    To assess the safety and tolerability of YH32367

  • Objective Response Rate (ORR)through dose expansion part completion, approximately 2.5 year

    To assess the ORR of YH32367 at the recommended Phase 2 dose (RP2D) according to RECIST v1.1 by blinded independent central reviews (BICR)