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

NCT05523947 · tracked via the Priya Life Science South Korea tracker

Sponsor

Yuhan Corporation

Phase

Phase 1/2

Started

2022-08-26

Last updated

2026-09-24

Condition(s) studied

HER2-Positive Solid Tumor

Investigational drug(s) / intervention(s)

YH32367

YH32367: Dose Escalation Part: 8 Cohorts. In this part, approximately 30 patients will be enrolled and patients are assigned to receive YH32367 at a starting dose and the dose being escalated/de-escalated in adjacent dose cohorts will be up to Dose level 8. Dose Expansion Part: 2 Cohorts(Cohort 1: Biliary tract cancer, Cohort 2: Solid tumors). The part will consist of multiple cohorts in patients who were treated with at least 1 prior gemcitabine- and/or cisplatin-based therapy, HER2 positive biliary tract cancer(Cohort 1); in patients who were treated with all available standard therapies and have no available options, HER2 positive solid tumor malignancies other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer(Cohort 2). Each cohort will enroll approximately 75 and 40 patients, respectively.

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Treatment-emergent adverse events (TEAEs) up to Day 21 — in 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)

Trial sites (19)

Facility	City	Region	Status
Dana Farber Cancer Institute	Boston	Massachusetts	Withdrawn
Vanderbilt Ingram Cancer Center	Nashville	Tennessee	Recruiting
Southern Oncology Clinical Research Unit	Adelaide	Australia	Terminated
Austin Health	Melbourne	Australia	Withdrawn
Breast Cancer Research Centre - WA	Perth	Australia	Withdrawn
Blacktown Hospital	Sydney	Australia	Recruiting
CHA Bundang Medical Center	Seongnam-si	Gyeonggi-do	Recruiting
Catholic University of Korea St. Vincent's Hospital	Suwon	Gyeonggi-do	Recruiting
Ajou University Hospital	Suwon	Gyeonggi-do	Recruiting
Gyeongsang National University Hospital	Jinju	Gyeongsangnam-do	Recruiting
Chungbuk National University Hospital	Cheongju-si	North Chungcheong	Recruiting
Gachon Gil University Medical Center	Incheon	South Korea	Recruiting
Korea University Anam Hospital	Seoul	South Korea	Recruiting
Seoul National University Hospital	Seoul	South Korea	Recruiting
Severance Hospital, Yonsei University Health System	Seoul	South Korea	Recruiting
Asan Medical Center	Seoul	South Korea	Recruiting
Samsung Medical Center	Seoul	South Korea	Recruiting
The Catholic University of Korea, St. Mary's hospital	Seoul	South Korea	Recruiting
Ulsan University Hospital	Ulsan	South Korea	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05523947 on ClinicalTrials.gov ↗ ← All trials in South Korea