A Phase I Study of SC-011 in People with Recurrent or Persistent Small Cell Lung Cancer

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Full Title

A Phase 1 Study of ABBV-011 as a Single-Agent and in Combination with Budigalimab (ABBV-181) in Subjects with Relapsed or Refractory Small Cell Lung Cancer

Purpose

The purpose of this study is to assess the safety of the investigational drug SC-011 in people with small cell lung cancer (SCLC) that has continued to grow or came back despite treatment. SC-011 is an antibody-drug conjugate (ADC). ADCs have two parts: an antibody that targets cancer cells and a chemotherapy drug that kills cancer cells.

The antibody part of SC-011 binds to a protein on some SCLC cells called SEZ6. When this happens, the ADC goes inside the cell, releasing the chemotherapy drug and destroying the cancer cell. ADCs are a type of targeted therapy that may have fewer side effects and be more effective than a treatment that is not directed toward a specific cancer target. SC-011 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 SCLC that continued to grow or came back despite at least one prior regimen of platinum-containing chemotherapy, with or without immunotherapy, but no more than three previous treatment regimens.
  • Patients must have cancers that test positive for SEZ6, which is the drug target in this study.  Patients who are interested in this study can give permission for tissue from their cancer to be tested for the presence of SEZ6.
  • Patients should recover from the serious side effects of previous therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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. Victoria Lai at 646-609-3793.

Protocol

19-391

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators