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 ↗

Phase 1 Active not recruiting 364 enrolled AbbVie

RandomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2019-02-21
Primary completion: 2027-06
Completion: 2027-06

Publications

Shimizu T, Powderly J, Abdul Razak A, LoRusso P, Miller KD, Kao S, Kongpachith S, Tribouley C, Graham M, Stoll B, Patel M, Sahtout M, Blaney M, Leibman R, Golan T, Tolcher A. First-in-human phase 1 dose-escalation results with livmoniplimab, an antibody targeting the GARP:TGF-ss1 complex, as monotherapy and in combination with the anti-PD-1 antibody budigalimab in patients with advanced solid tumors. Front Oncol. 2024 Oct 29;14:1376551. doi: 10.3389/fonc.2024.1376551. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budigalimab	Monoclonal antibody	500 mg	Intravenous
Subject	Livmoniplimab	Monoclonal antibody	3 mg	Intravenous
Subject	Livmoniplimab	Monoclonal antibody	1500 mg	Intravenous

Indications

No indication recorded.