A Phase I Study of SC-002 in Patients with Recurrent or Persistent Small Cell Lung Cancer or Large Cell Neuroendocrine Cancer

Full Title

A Phase 1a/1b Dose Escalation and Expansion Study of Single-agent SC-002 in Subjects with Relapsed or Refractory Small Cell Lung Cancer, Large Cell Neuroendocrine Carcinoma, and Other Advanced Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug SC-002 that can be given safely in patients with small cell lung cancer or large cell neuroendocrine cancer that has come back or continued to grow despite prior treatment.

SC-002 is called an "antibody-drug conjugate." It contains three parts: an antibody, an active chemotherapy drug, and a "linker" that connects the antibody to the anticancer drug. The antibody portion attaches to a protein on cancer cells called DLL3; once inside the cancer cell, the active drug can damage the cell. SC-002 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 small cell lung cancer or large cell neuroendocrine cancer that has continued to grow or came back despite no more than two prior regimens of therapy, at least one of which contained a platinum drug.
  • At least 4 weeks must pass since the completion of prior chemotherapy and 3 weeks since any major surgery and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of 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. Charles Rudin at 646-888-4336.

Protocol

15-194

Phase

I

Investigator

Co-Investigators

Locations