Treatment with YH32367 for HER2 Positive Advanced Solid Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety, tolerability, pharmacokinetics, and anti-tumor activity of YH32367, a bispecific antibody targeting HER2 and 4-1BB, in patients with HER2-positive locally advanced or metastatic solid tumors. The study consists of two parts: a Dose Escalation phase to determine the Maximum Tolerated Dose (MTD) and a Dose Expansion phase to confirm the safety and efficacy at the recommended dose. Participants must provide tumor tissue samples and have measurable lesions to qualify for the trial.

Why it matters

Who can join: the full rules

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

Where it's running

• Vanderbilt Ingram Cancer Center
  Nashville, Tennessee, United States Recruiting
• Blacktown Hospital
  Sydney, Australia Recruiting
• CHA Bundang Medical Center
  Seongnam-si, Gyeonggi-do, South Korea Recruiting
• Catholic University of Korea St. Vincent's Hospital
  Suwon, Gyeonggi-do, South Korea Recruiting
• Ajou University Hospital
  Suwon, Gyeonggi-do, South Korea Recruiting
• Gyeongsang National University Hospital
  Jinju, Gyeongsangnam-do, South Korea Recruiting

Study contacts

• Principal investigator: Hyejin Choi — Severance Hospital
• Study coordinator: Clinical Operation Team 1
• Email: clinicaltrials@yuhan.co.kr
• Phone: +82-2-828-0065

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.