A Phase I/II Study of HPN328 Immunotherapy in People with Cancer That Makes the DLL3 Protein

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Full Title

A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 in Patients with Advanced Cancers Associated with Expression of Delta-Like Canonical Notch Ligand 3 (DLL3) Who Have Failed Standard Available Therapy

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy drug HPN328 that can be given safely in patients with advanced small cell lung cancer (SCLC) or other solid tumors that make the DLL3 protein and cannot be successfully treated with standard therapies.

HPN328 is designed to target DLL3, which is found in high amounts on cancer cells but not on healthy cells. By targeting DLL3, HPN328 may help the immune system recognize and kill cancer cells. It 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 SCLC or another solid tumor that makes DLL3 and continues to grow despite standard treatments.
  • At least 3 weeks must pass between the completion of previous therapies and receipt of HPN328.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Adam Schoenfeld at 646-608-4042.

Protocol

21-329

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator