ABBV-011 + Budigalimab for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, ABBV-011, alone and with budigalimab, in patients whose small cell lung cancer has returned or didn't respond to treatment. ABBV-011 aims to kill cancer cells directly, and budigalimab boosts the immune system to fight the cancer.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you must have stopped any prior anticancer therapy at least 4 weeks before starting the study drug.
What safety data exists for ABBV-011 and Budigalimab in humans?
The research articles discuss immune-related adverse events (side effects related to the immune system) associated with immune checkpoint inhibitors, which are similar types of treatments to Budigalimab. These side effects can include lung issues and colitis (inflammation of the colon), highlighting the importance of monitoring and managing these reactions.12345
How is the drug combination of ABBV-011 and Budigalimab unique for treating small cell lung cancer?
What data supports the effectiveness of the drug ABBV-011 + Budigalimab for Small Cell Lung Cancer?
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
This trial is for adults with small cell lung cancer that's come back or hasn't responded to treatment. They should have had no more than three prior therapies and can't be eligible for curative treatments. Participants need a certain level of health, including organ function, and an expected lifespan of at least 12 weeks. They must not have serious heart conditions, liver issues like cirrhosis, or a history of severe drug reactions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Single-agent ABBV-011 dose regimen finding cohort
Treatment Part B
Single-agent ABBV-011 dose expansion cohort
Treatment Part C
ABBV-011 and budigalimab (ABBV-181) combination escalation and expansion cohort
Treatment Part D
Single-agent ABBV-011 dose-evaluating cohort for Japan
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABBV-011
- Budigalimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois