NCT02099058

A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors

A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, and nivolumab in participants with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D.

Conditions

• Advanced Solid Tumors Cancer

Interventions

Type	Name	Description
DRUG	Osimertinib	It is administered orally everyday.
DRUG	Nivolumab	It is an intravenous infusion administered every 14 days.
DRUG	Telisotuzumab vedotin	It is administered by infusion in 21-day dosing cycles.
DRUG	Telisotuzumab vedotin	It is administered by infusion in 28-day dosing cycles.
DRUG	Erlotinib	It is administered orally everyday.

Timeline

• Start date: 2014-01-15
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2014-03-28
• Last updated: 2025-08-14

Locations

36 sites across 9 countries: United States, Belgium, Finland, France, Italy, Japan, Netherlands, South Korea, Taiwan

Regulatory

• FDA-regulated drug study