NCT03893955

A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Combinations of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Subjects With Locally Advanced or Metastatic Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. The dose-expansion phase can begin once the recommended phase 2 dose/maximum tolerated dose (RP2D/MTD) is determined in the dose-escalation phase.

Conditions

• Cancer
• Advanced Solid Tumors
• Triple-Negative Breast Cancer (TNBC)
• Non-small-cell-lung-cancer (NSCLC)
• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	ABBV-927	Intravenous (IV) Infusion
DRUG	ABBV-368	Intravenous (IV) Infusion
DRUG	ABBV-181	Intravenous (IV) Infusion
DRUG	Carboplatin	Intravenous (IV) Infusion
DRUG	Nab-paclitaxel	Intravenous (IV) Infusion

Timeline

• Start date: 2019-05-21
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2019-03-28
• Last updated: 2025-08-12

Locations

26 sites across 6 countries: United States, Australia, France, Israel, Spain, Taiwan

Regulatory

• FDA-regulated drug study