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ABBV-011 + Budigalimab for Small Cell Lung Cancer
Study Summary
This trial is testing a new drug, ABBV-011, for small cell lung cancer that has come back or didn't respond to other treatments. The study has 4 parts, testing different doses of the drug and how well it works alone or with another drug, budigalimab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have recovered from major side effects of previous treatments, except for hair loss.My small cell lung cancer tissue tests positive for a specific target.You are expected to live for at least 12 more weeks.You have had a severe skin reaction to a medication in the past.I have a history of liver issues or alcohol dependence.I have had a stroke or serious heart condition in the last 6 months.My body weight is under 35 kilograms.I do not have a history of or current interstitial lung disease.I am using immunosuppressants, with some exceptions allowed.I do not have a serious infection currently or recently.I have a history of inflammatory bowel disease.I have never had a primary immunodeficiency, organ transplant, or tuberculosis.I have a tumor or lymph node large enough to be measured on a CT scan.You have an ongoing autoimmune disease, unless the study protocol says it's okay for you to participate.I am fully active or can carry out light work.I have had a stem cell transplant before.I have a history of heart rhythm problems.I currently have COVID-19.The doctor thinks you still have problems with your red blood cells breaking down.I have not received a live vaccine in the last 30 days.My small cell lung cancer has returned or didn't respond after 1-3 treatments with platinum-based chemotherapy, and there's no cure available.I do not have active lung inflammation or a history of it that needed steroid treatment.I do not have severe nerve pain or damage.My SCLC tumor is SEZ6 positive.I have had cancer before, but it fits the exceptions listed.It has been over 4 weeks since my last cancer treatment.My blood, liver, nerves, and kidneys are functioning well.My tumor tests positive for the specific target needed for Parts B and C of the study.
- Group 1: Part A: ABBV-011 Dose Escalation
- Group 2: Part B: ABBV-011 Dose Expansion
- Group 3: Part C: ABBV-011 + Budigalimab Escalation and Expansion
- Group 4: Part D: ABBV-011 Dose Evaluation for Japan
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there extant investigations into ABBV-011?
"ABBV-011 was first tested at Highlands Oncology Group, PA /ID# 207176 in 2018; since then there have been 5 studies that have completed research. At this time, 6 trials are actively recruiting participants with a considerable number of these occurring near Nashville, Tennessee."
What is the upper limit for enrollees in this research endeavor?
"That is accurate. According to clinicaltrials.gov, this scientific trial initially uploaded on October 24th 2018 and was recently revised on the 5th of October 2022 is currently recruiting participants. A total of 233 patients must be recruited across 25 different sites in order for the study to succeed."
Is this research endeavor still in the recruitment phase?
"According to clinicaltrials.gov, this medical trial is actively recruiting participants, having initially been posted on October 24th 2018 and last amended on October 5th 2022."
What are the potential risks associated with ABBV-011?
"Limited data exists on the efficacy and safety of ABBV-011, thus our team at Power gives it a score of 1."
Has this medical investigation been done previously, or is it a pioneering effort?
"Research into ABBV-011 started in 2018 with an initial trial backed by AbbVie. This first study, which involved 233 participants, was successful and the drug received Phase 1 approval. As of today, 6 studies are being conducted around the world across 81 cities in 13 distinct countries."
What are the central goals of this experiment?
"The objective of this long-term clinical trial, which will span up to 5 years from the day a patient receives their first dosage, is to establish Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RPTD) for ABBV-011. Secondary objectives include defining Steady State Volume of Distribution (Vss), Area Under the Serum Concentration Curve (AUCinf), and Time To Maximum Serum Concentration (Tmax)."
In what regions is access to this clinical trial being granted?
"Presently, 25 medical centres are included in this trial; for example, Highlands Oncology Group /ID# 207176in Nashville, Cancer Care at Vanderbilt-Ingram Cancer Center /ID# 207551 in Boston and Highlands Oncology Group Springdale/ ID #207176 in Columbus. Additionally, there are other participating locations throughout the country."
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