A Study of ABBV-927, an Immunotherapy, in Participants With Advanced Solid Tumors

Description

This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with nivolumab in participants with advanced solid tumors.

Study Start Date

February, 28 2017

Estimated Completion Date

December 2019

Interventions

  • Drug: ABBV-927
  • Drug: Nivolumab

Study ID

AbbVie -- M15-862

Status

Recruiting

Trial ID

NCT02988960

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

180

Sponsor

AbbVie

Inclusion Criteria

  • Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • Participants have adequate bone marrow, kidney and liver function.
  • Participants with a history of chronic heart failure or significant cardiovascular disease must have an echocardiogram indicating left ventricular ejection fraction greater than or equal to 45% within 28 days prior to the first dose of study drug.
  • Participants must have creatinine clearance greater than or equal to 50 mL/min as measured by 24-hour urine or estimated by the Cockcroft-Gault formula.
  • Participants must have total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase and alanine aminotransferase less than or equal to 2.5 times ULN.
  • Participants in all monotherapy arms must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies.
  • Participants in all combination therapy arms must have an advanced solid tumor for which the indicated standard of care is nivolumab. At the discretion of the Sponsor, subjects with an advanced solid tumor which has progressed on an approved anti-PD1/anti-PDL1 agent may be enrolled.
  • The Sponsor may decide to limit the specific tumor types selected or treatment settings for specific arms based on evidence gathered.

Exclusion Criteria

  • Participant must not have an active or prior documented autoimmune disease in the last 2 years.
  • Participant must not have current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
  • Participant must not have a history of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
  • Participant must not have a history of a coagulopathy or a platelet disorder.
  • Participant must not have a prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis while receiving immunotherapy.
  • Participant must not have a known uncontrolled malignancy of the central nervous system.
  • Participants in all combination therapy arms must not have a history of exposure to an immunotherapy experiencing an immune-mediated adverse event that required permanent discontinuation of the immunotherapy.
  • Female participants must not be pregnant, breastfeeding or considering becoming pregnant during the study or for approximately 3 months after the last dose of study drug.
  • Male participants must not be considering fathering a child or donating sperm during the study or for approximately 3 months after the last dose of study drug.

Gender

All

Ages

18 Years to 99 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (42)

Study Location Distance Name Phone Email
Massachusetts General Hospital ID 155267 - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital ID 155267 - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital ID 155267 - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital ID 155267 - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital ID 155267 - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital ID 155267 - Boston, Massachusetts 2.8 miles None None None
Virginia Cancer Specialists PC ID 155266 - Fairfax, Virginia 404.7 miles None None None
Virginia Cancer Specialists PC ID 155266 - Fairfax, Virginia 404.7 miles None None None
Virginia Cancer Specialists PC ID 155266 - Fairfax, Virginia 404.7 miles None None None
Virginia Cancer Specialists PC ID 155266 - Fairfax, Virginia 404.7 miles None None None
Virginia Cancer Specialists PC ID 155266 - Fairfax, Virginia 404.7 miles None None None
Virginia Cancer Specialists PC ID 155266 - Fairfax, Virginia 404.7 miles None None None
Carolina BioOncology Institute PLLC ID 155265 - Huntersville, North Carolina 712.0 miles None None None
Carolina BioOncology Institute PLLC ID 155265 - Huntersville, North Carolina 712.0 miles None None None
Carolina BioOncology Institute PLLC ID 155265 - Huntersville, North Carolina 712.0 miles None None None
Carolina BioOncology Institute PLLC ID 155265 - Huntersville, North Carolina 712.0 miles None None None
Carolina BioOncology Institute PLLC ID 155265 - Huntersville, North Carolina 712.0 miles None None None
Carolina BioOncology Institute PLLC ID 155265 - Huntersville, North Carolina 712.0 miles None None None
The University of Chicago Medical Center ID 155264 - Chicago, Illinois 848.0 miles None None None
The University of Chicago Medical Center ID 155264 - Chicago, Illinois 848.0 miles None None None
The University of Chicago Medical Center ID 155264 - Chicago, Illinois 848.0 miles None None None
The University of Chicago Medical Center ID 155264 - Chicago, Illinois 848.0 miles None None None
The University of Chicago Medical Center ID 155264 - Chicago, Illinois 848.0 miles None None None
The University of Chicago Medical Center ID 155264 - Chicago, Illinois 848.0 miles None None None
The Sarah Cannon Research Institute ID 158654 - Nashville, Tennessee 942.8 miles None None None
The Sarah Cannon Research Institute ID 158654 - Nashville, Tennessee 942.8 miles None None None
The Sarah Cannon Research Institute ID 158654 - Nashville, Tennessee 942.8 miles None None None
The Sarah Cannon Research Institute ID 158654 - Nashville, Tennessee 942.8 miles None None None
The Sarah Cannon Research Institute ID 158654 - Nashville, Tennessee 942.8 miles None None None
The Sarah Cannon Research Institute ID 158654 - Nashville, Tennessee 942.8 miles None None None
The University of Texas MD Anderson Cancer Center ID 155263 - Houston, Texas 1,609.9 miles None None None
The University of Texas MD Anderson Cancer Center ID 155263 - Houston, Texas 1,609.9 miles None None None
The University of Texas MD Anderson Cancer Center ID 155263 - Houston, Texas 1,609.9 miles None None None
The University of Texas MD Anderson Cancer Center ID 155263 - Houston, Texas 1,609.9 miles None None None
The University of Texas MD Anderson Cancer Center ID 155263 - Houston, Texas 1,609.9 miles None None None
The University of Texas MD Anderson Cancer Center ID 155263 - Houston, Texas 1,609.9 miles None None None
The Angeles Clinic and Research Institute ID 156324 - Los Angeles, California 2,606.1 miles None None None
The Angeles Clinic and Research Institute ID 156324 - Los Angeles, California 2,606.1 miles None None None
The Angeles Clinic and Research Institute ID 156324 - Los Angeles, California 2,606.1 miles None None None
The Angeles Clinic and Research Institute ID 156324 - Los Angeles, California 2,606.1 miles None None None
The Angeles Clinic and Research Institute ID 156324 - Los Angeles, California 2,606.1 miles None None None
The Angeles Clinic and Research Institute ID 156324 - Los Angeles, California 2,606.1 miles None None None

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