NCT03821935

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 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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 364 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Advanced Solid Tumors Cancer

Interventions

Type	Name	Description
DRUG	Livmoniplimab	Liquid for intravenous infusion.
DRUG	Budigalimab	Lyophilized powder for solution for intravenous infusion.

Timeline

• Start date: 2019-02-21
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2019-01-30
• Last updated: 2025-05-25

Locations

64 sites across 14 countries: United States, Australia, Belgium, Canada, France, Germany, Israel, Italy, Japan, Poland, Puerto Rico, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study