RightFit
RecruitingPhase 1 / Phase 2

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

A Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32367 in Patients With HER2-Positive Locally Advanced or Metastatic Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests YH32367 in people for the first time. It is for people with HER2-positive solid tumors that have grown into nearby areas or spread to other parts of the body. It looks at safety, side effects, how the body handles the drug, and how it works against cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • In the dose-escalation part, which tests increasing doses, a tissue test must show HER2-positive cancer. This means the cancer has high levels of a protein called HER2.
  • In the dose-expansion part, you must have at least one tumor that can be measured.
  • You must provide a tumor tissue sample in either part.
  • Dose-expansion group 1: A tissue test must show HER2-positive biliary tract cancer (cancer in the system that carries bile).
  • Dose-expansion group 2: A tissue test must show HER2-positive solid cancer that has spread. This group does not include breast cancer, biliary tract cancer, or adenocarcinoma (gland-cell cancer) of the stomach or where the food pipe meets the stomach.

Who can't join

  • Cancer spread to the brain or spinal cord that is not controlled, pressure on the spinal cord, or cancer in the lining around the brain and spinal cord.
  • Acute coronary syndrome (a sudden drop in blood flow to the heart) or heart failure.
  • Interstitial lung disease (damage or scarring in the lungs) or pneumonitis (lung swelling).
  • A history of a second, separate cancer.
  • HIV (a virus that weakens the body's ability to fight infections).
  • Active long-term hepatitis B or hepatitis C (viruses that affect the liver).
  • Steroid treatment that affects the whole body.
  • An autoimmune disease, in which the body's defenses attack healthy tissue.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

MA

TN