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

NCT02099058 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2025-08-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-15
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Finland
  • France
  • Italy
  • Japan
  • Netherlands
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02099058 on ClinicalTrials.gov