A Phase I Study of HPN536 in Patients with Advanced Cancers, including Mesothelioma, Pancreatic Cancer, and Ovarian Cancer, that Continue to Grow Despite Standard Therapy

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Full Title

A Phase 1/2a Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN536 in Patients with Advanced Cancers Associated with Mesothelin Expression Who Have Failed Standard Available Therapy

Purpose

HPN536 is an investigational drug that attaches to a protein on the surface of some cancer cells called mesothelin, as well as proteins on the surface of immune system cells. HPN536 brings immune system cells into contact with cancer cells, which stimulates the immune system to fight the cancer.

The purpose of this study is to find the highest dose of the HPN536 that can be given safely in patients with advanced cancers that have mesothelin that continue to grow or came back despite prior treatment. Examples include pancreatic, ovarian, or fallopian tube cancers or peritoneal or pleural mesothelioma. HPN536 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced pancreatic, ovarian, or fallopian tube cancer or peritoneal or pleural mesothelioma that came back or continues to grow despite standard treatment.
  • At least 2 weeks must pass between the completion of prior therapy and receipt of HPN536.
  • Patients must be physically well enough that they are capable of all self-care and all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Michael Offin at 646-608-3763.

Protocol

20-435

Phase

I/II

Investigator