A Study of ABBV-011 Alone and in Combination With Budigalimab (ABBV-181) in Participants With Relapsed or Refractory Small Cell Lung Cancer
Public ClinicalTrials.gov record NCT03639194. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, open-label, Phase 1 study of ABBV-011 given as a single agent and in combination with budigalimab (ABBV-181) in participants with relapsed or refractory small cell lung cancer (SCLC). The study consists of 4 parts: Part A is a single-agent ABBV-011 dose regimen finding cohort; followed by Part B, a single-agent ABBV-011 dose expansion cohort; and then Part C, an ABBV-011 and budigalimab (ABBV-181) combination escalation and expansion cohort; Part D, single-agent ABBV-011 dose-evaluating cohort for Japan.
Study identification
- NCT ID
- NCT03639194
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 132 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 24, 2018 (Actual)
- Primary completion
- Jan 25, 2024 (Actual)
- Completion
- Jan 25, 2024 (Actual)
- Last update posted
- Feb 9, 2024
2018 – 2024
United States locations
- U.S. sites
- 21
- U.S. states
- 17
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham - Main /ID# 207295 | Birmingham | Alabama | 35233 | — |
| Highlands Oncology Group, PA /ID# 207176 | Springdale | Arkansas | 72762 | — |
| University of California, Davis Comprehensive Cancer Center /ID# 207548 | Sacramento | California | 95817 | — |
| Yale School of Medicine /ID# 207559 | New Haven | Connecticut | 06519 | — |
| University of Iowa Hospitals and Clinics /ID# 207560 | Iowa City | Iowa | 52242 | — |
| University of Kentucky Chandler Medical Center /ID# 208217 | Lexington | Kentucky | 40536 | — |
| Massachusetts General Hospital /ID# 207549 | Boston | Massachusetts | 02114 | — |
| Dana-Farber Cancer Institute /ID# 213032 | Boston | Massachusetts | 02215 | — |
| University of Michigan Comprehensive Cancer Center /ID# 207177 | Ann Arbor | Michigan | 48109-5000 | — |
| Henry Ford Hospital /ID# 233539 | Detroit | Michigan | 48202 | — |
| Washington University-School of Medicine /ID# 207168 | St Louis | Missouri | 63110 | — |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 208216 | New York | New York | 10065-6007 | — |
| Duke Cancer Center /ID# 207547 | Durham | North Carolina | 27710 | — |
| UH Cleveland Medical Center /ID# 207561 | Cleveland | Ohio | 44106 | — |
| The Ohio State University /ID# 207552 | Columbus | Ohio | 43210 | — |
| Tennessee Oncology, PLLC /ID# 207175 | Nashville | Tennessee | 37203 | — |
| Vanderbilt Ingram Cancer Center /ID# 207551 | Nashville | Tennessee | 37232-0021 | — |
| NEXT Oncology /ID# 207167 | San Antonio | Texas | 78229 | — |
| University of Utah /ID# 207553 | Salt Lake City | Utah | 84112-5500 | — |
| University of Washington /ID# 207557 | Seattle | Washington | 98109 | — |
| Univ of Wisconsin Hosp/Clinics /ID# 207556 | Madison | Wisconsin | 53792-0001 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03639194, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 9, 2024 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03639194 live on ClinicalTrials.gov.