AbbVie-M17-327 (Small Cell Lung Cancer)
What is the Purpose of this Study?
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)
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)
What is the Condition Being Studied?
Relapsed or Refractory Small Cell Lung Cancer (SCLC)
Who Can Participate in this 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.
Age Group
Adults
Participating Institutions
What is Involved?
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.
Study Details
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
Principal Investigator
Protocol Number
IRB:
PRO00101099
NCT:
NCT03639194
ClinicalTrials.gov
View on ClinicalTrials.gov