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Monoclonal Antibodies

ABBV-011 + Budigalimab for Small Cell Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed small cell lung cancer (SCLC) that is relapsed or refractory following at least 1 prior platinum-containing chemotherapy, but no more than 3 total prior lines of therapy, and with no curative therapy available
Measurable disease, defined as at least 1 tumor lesion greater than or equal to 10 mm in the longest diameter or a lymph node greater than or equal to 15 mm in short axis measurement assessed by computed tomography (CT) scan, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years after the first participant receives first dose of study drug
Awards & highlights

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.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests ABBV-011 alone and combined with Budigalimab in people whose lung cancer has relapsed or is resistant to treatment. It includes dose-finding and expansion phases for both the single agent (ABBV-011) and the combination therapy with Budigalimab.See study design
What are the potential side effects?
Potential side effects may include typical reactions to immunotherapy such as fatigue, allergic responses to ingredients in the drugs, liver problems, neurological symptoms due to inflammation caused by immune response, digestive disturbances from off-target effects on healthy cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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I have a tumor or lymph node large enough to be measured on a CT scan.
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I am fully active or can carry out light work.
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I have recovered from major side effects of previous treatments, except for hair loss.
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My blood, liver, nerves, and kidneys are functioning well.
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My tumor tests positive for the specific target needed for Parts B and C of the study.
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My small cell lung cancer tissue tests positive for a specific target.
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It has been over 4 weeks since my last cancer treatment.
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My SCLC tumor is SEZ6 positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years after the first participant receives first dose of study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years after the first participant receives first dose of study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Laboratory Abnormaities
Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011
Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RPTD) of ABBV-011 in Combination with Budigalimab
+4 more
Secondary outcome measures
Accumulation Ratio of ABBV-011
Apparent Terminal Half-Life (T1/2) of ABBV-011
Area Under the Serum Concentration-Time Curve (AUCinf) of ABBV-011
+13 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part D: ABBV-011 Dose Evaluation for JapanExperimental Treatment1 Intervention
ABBV-011 via intravenous administration will be administered every 3 weeks (Q3wk), on Day 1 of each 21-day cycle or alternate dosing regimens.
Group II: Part C: ABBV-011 + Budigalimab Escalation and ExpansionExperimental Treatment2 Interventions
ABBV-011 via intravenous administration at various doses and dosing regimens starting at least 1 dose level below the recommended single-agent dose of ABBV-011 for Part B plus Budigalimab via intravenous administration at fixed doses and various dosing regimens.
Group III: Part B: ABBV-011 Dose ExpansionExperimental Treatment1 Intervention
ABBV-011 via intravenous administration at dose regimen(s) that will not exceed the maximum tolerated dose determined in Part A.
Group IV: Part A: ABBV-011 Dose EscalationExperimental Treatment1 Intervention
ABBV-011 via intravenous administration at various doses and dosing regimens until the maximum tolerated dose and/or the recommended Part B dose(s) is declared.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABBV-011
2018
Completed Phase 1
~140
Budigalimab
2021
Completed Phase 1
~170

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
946 Previous Clinical Trials
496,340 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
387 Previous Clinical Trials
141,021 Total Patients Enrolled

Media Library

ABBV-011 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03639194 — Phase 1
Small Cell Lung Cancer Research Study Groups: Part A: ABBV-011 Dose Escalation, Part B: ABBV-011 Dose Expansion, Part C: ABBV-011 + Budigalimab Escalation and Expansion, Part D: ABBV-011 Dose Evaluation for Japan
Small Cell Lung Cancer Clinical Trial 2023: ABBV-011 Highlights & Side Effects. Trial Name: NCT03639194 — Phase 1
ABBV-011 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03639194 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI
~21 spots leftby Mar 2025