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NCT03821935 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Advanced Solid Tumors Cancer, sponsored by AbbVie.
- Active
- Registry status
- Phase 1
- Development phase
- 364
- Enrollment target
- 20
- Study locations
NCT03821935 is a Phase 1 study of Advanced Solid Tumors Cancer that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 364 participants, above the 314-participant average among 9 other Advanced Solid Tumors Cancer trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT03821935, a Phase 1 study of Advanced Solid Tumors Cancer, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 364 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Budigalimab
- DRUG Livmoniplimab
Study Locations (20)
Texas
- Renovatio clinical /ID# 265109 - El Paso
- NEXT Oncology /ID# 208930 - San Antonio
- Renovatio Clinical /ID# 265054 - The Woodlands
California
- City of Hope National Medical Center /ID# 265620 - Duarte
- City of Hope Orange County Lennar Foundation Cancer Center /ID# 270785 - Irvine
Florida
- AdventHealth Celebration /ID# 224860 - Celebration
- Duplicate_AdventHealth Cancer Institute - Orlando /ID# 226953 - Orlando
Indiana
- Indiana Univ School Medicine /ID# 208384 - Indianapolis
- Community Health Network, Inc. /ID# 257032 - Indianapolis
New York
- NYU Langone Medical Center /ID# 209822 - New York
- Icahn School of Medicine at Mount Sinai /ID# 264653 - New York
Arkansas
- Highlands Oncology Group, PA /ID# 218942 - Springdale
Connecticut
- Yale University School of Medicine /ID# 208356 - New Haven
Michigan
- Univ Michigan Med Ctr /ID# 221129 - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 364 participants |
| Start Date | 2019-02-21 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03821935
The ClinicalTrials.gov registry entry for NCT03821935 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 364 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 314-participant average among 9 other Advanced Solid Tumors Cancer trials with a reported enrollment target (16% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Advanced Solid Tumors Cancer appearing as the primary indexed condition, and to 2 interventions - of which Budigalimab is the first listed.
NCT03821935 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Texas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03821935 about?
NCT03821935 is a clinical study titled "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". 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...
What is the current status of trial NCT03821935?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 364 participants. The study started on 2019-02-21. Estimated completion is 2027-06.
What conditions does trial NCT03821935 study?
This clinical trial studies the following conditions: Advanced Solid Tumors Cancer.
What interventions are being tested in trial NCT03821935?
The interventions under investigation include: Budigalimab (DRUG), Livmoniplimab (DRUG).
Who is sponsoring clinical trial NCT03821935?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03821935 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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