AbbVie-M17-327 (Small Cell Lung Cancer) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to see how an experimental drug called ABBV-011 works in your body and against your cancer. Participants may receive ABBV-011 alone or in combination with another experimental drug called budigalimab (ABBV-181). This is the first research study where people will receive ABBV-011 alone or in combination with budigalimab.
Relapsed or Refractory Small Cell Lung Cancer (SCLC)
Who Can Participate in the Study?
Adults age 18 or older who:
- Are diagnosed with relapsed or refractory SCLC
- Test positive for the SEZ6 protein
For more information about who can be in this study, please contact the study team.
What is Involved?
This study is divided into 3 parts: pre-screening, screening, and the study dosing period.
During the pre-screening period you will:
- Have tumor biopsies done to test for a type of protein called SEZ6
- Proceed to the screening period if this protein is found
During the screening period you will:
- Visit the clinic 1 or 2 times
- Have physical exams and blood tests
- Get an electrocardiogram (ECG)
- Have eye tests
- Have imaging scans (CT and MRI)
During the study dosing period you will:
- Receive the study drug(s) through an IV
- Return to the clinic occasionally for exams and tests (blood draws, ECGs, etc.)
- Be randomly assigned (like flipping a coin) to 1 of 2 groups
-- Group 1 will receive a single study drug (ABBV-011) on its own
-- Group 2 will receive a combination of study drugs (ABBV-001 + budigalimab)