Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors
Public ClinicalTrials.gov record NCT03821935. 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 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Locally Advanced or Metastatic Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151) administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of livmoniplimab alone and in combination with budigalimab. The study will consist of 2 parts: dose escalation and dose expansion.
Study identification
- NCT ID
- NCT03821935
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 364 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
- Feb 21, 2019 (Actual)
- Primary completion
- Jun 2027 (Estimated)
- Completion
- Jun 2027 (Estimated)
- Last update posted
- May 25, 2025
2019 – 2027
United States locations
- U.S. sites
- 21
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highlands Oncology Group, PA /ID# 218942 | Springdale | Arkansas | 72762 | — |
| City of Hope National Medical Center /ID# 265620 | Duarte | California | 91010 | — |
| City of Hope Orange County Lennar Foundation Cancer Center /ID# 270785 | Irvine | California | 92618 | — |
| Yale University School of Medicine /ID# 208356 | New Haven | Connecticut | 06510 | — |
| AdventHealth Celebration /ID# 224860 | Celebration | Florida | 34747-4970 | — |
| Duplicate_AdventHealth Cancer Institute - Orlando /ID# 226953 | Orlando | Florida | 32804 | — |
| Indiana Univ School Medicine /ID# 208384 | Indianapolis | Indiana | 46202 | — |
| Community Health Network, Inc. /ID# 257032 | Indianapolis | Indiana | 46250-2042 | — |
| Univ Michigan Med Ctr /ID# 221129 | Ann Arbor | Michigan | 48109 | — |
| Washington University-School of Medicine /ID# 259684 | St Louis | Missouri | 63110 | — |
| Intermountain Health West End Clinic Gynecologic Oncology /ID# 266171 | Billings | Montana | 59106 | — |
| NYU Langone Medical Center /ID# 209822 | New York | New York | 10016-6402 | — |
| Icahn School of Medicine at Mount Sinai /ID# 264653 | New York | New York | 10029 | — |
| Carolina BioOncology Institute /ID# 208358 | Huntersville | North Carolina | 28078 | — |
| The Ohio State University - The James /ID# 217611 | Columbus | Ohio | 43210-1240 | — |
| Ou Health - Stephenson Cancer Center /ID# 268826 | Oklahoma City | Oklahoma | 73104 | — |
| Sarah Cannon Research Institute (SMO/Network/Consortium) /ID# 264900 | Nashville | Tennessee | 37203-5755 | — |
| Renovatio clinical /ID# 265109 | El Paso | Texas | 79915-1803 | — |
| NEXT Oncology /ID# 208930 | San Antonio | Texas | 78229 | — |
| Renovatio Clinical /ID# 265054 | The Woodlands | Texas | 77380-3181 | — |
| University of Washington Medical Center /ID# 268854 | Seattle | Washington | 98195 | — |
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 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03821935, 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 May 25, 2025 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03821935 live on ClinicalTrials.gov.