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ACTIVE NOT RECRUITING 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

NCT03821935 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

AbbVie

603 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 364 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03821935 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Texas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03821935?

The interventions under investigation include: Budigalimab (DRUG), Livmoniplimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03821935?

This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial