NCT03071757

A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors

A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer \[TNBC\] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.

Detailed description

Recruitment is closed in Part 1A; subjects are in maintenance

Conditions

• Advanced Solid Tumors Cancer

Interventions

Type	Name	Description
DRUG	ABBV-368	Intravenous infusion
DRUG	ABBV-181	Intravenous infusion

Timeline

• Start date: 2017-03-21
• Primary completion: 2022-04-13
• Completion: 2022-04-13
• First posted: 2017-03-07
• Last updated: 2022-04-28

Locations

27 sites across 6 countries: United States, France, Japan, Puerto Rico, Spain, Taiwan

Regulatory

• FDA-regulated drug study