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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: Active Phase 1 study of Advanced Solid Tumors Cancer, sponsored by AbbVie.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation portion of the study.

Conditions Studied

Advanced Solid Tumors Cancer

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

FieldValue
Enrollment Target 364 participants
Start Date 2019-02-21
Est. Completion 2027-06
Phase Phase 1
AbbVie

526 total trials

What the registry record for NCT03821935 still lists

NCT03821935 is an interventional study that assigns participants to a tested intervention. The registered 364 participants enrollment target is mid-sized for trials with a published cap, above the 314-participant average among 9 other Advanced Solid Tumors Cancer trials with a reported enrollment target (16% higher).

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 names 20 study sites across 14 states, led by 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.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumors Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03821935's enrollment target sits among peer trials

364 2nd of 9 the highest of 9 other Advanced Solid Tumors Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumors Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03821935, the US trial registry maintained by the National Library of Medicine. NCT03821935 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.