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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
AbbVie
Study ID
NCT02955251
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • ABBV-428 — DRUG
    ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.
  • Nivolumab — DRUG
    Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.

Study Details

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.

Key Dates

Start date
Nov 18, 2016
Status verified
Jul 2020
Primary completion
Oct 29, 2019
Completion
Oct 29, 2019

Study Design

Enrollment
61 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    ABBV-428 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle).
  • Experimental: Arm A, B, and C
    Additional participants (with ovarian cancer, NSCLC, etc.) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-428.
  • Experimental: Arm D
    Additional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-428 plus nivolumab.
  • Experimental: Arm 2
    ABBV-428 plus nivolumab.

Primary Outcome Measure

Number of participants with adverse events [ Time Frame: First dose of study drug through at least 100 days after end of treatment; up to 2 years after last participants first dose ]

Locations (7)

FacilityCityStateZIPSite coordinators
HonorHealth Research Institute - Pima /ID# 155461ScottsdaleArizona85258-2345-
UC Davis Comprehensive Cancer Center - Main /ID# 154439SacramentoCalifornia95817-
University of Chicago /ID# 154440ChicagoIllinois60637-1443-
Fox Chase Cancer Center /ID# 170665PhiladelphiaPennsylvania19111-
Greenville Hospital System /ID# 154437GreenvilleSouth Carolina29605-
MD Anderson Cancer Center at Texas Medical Center /ID# 154441HoustonTexas77030-4000-
South Texas Accelerated Research Therapeutics /ID# 154442San AntonioTexas78229-

Find similar trials in Scottsdale, AZ

By research site
HonorHealth Research Institute - Pima· Scottsdale, AZUC Davis Comprehensive Cancer Center - Main· Sacramento, CAUniversity of Chicago· Chicago, ILFox Chase Cancer Center· Philadelphia, PAGreenville Hospital System· Greenville, SCMD Anderson Cancer Center at Texas Medical Center· Houston, TX

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