MedTrace Logo

A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors

NCT02955251 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2020-07-20

No results posted yet for this study

Summary

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.

Conditions

  • Advanced Solid Tumors Cancer

Interventions

DRUG

ABBV-428

ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.

DRUG

Nivolumab

Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-18
Primary Completion
2019-10-29
Completion
2019-10-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • 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 NCT02955251 on ClinicalTrials.gov