Antibody DS-8273a Administered in Combination With Nivolumab in Subjects With Advanced Colorectal Cancer

PHASE1TerminatedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

December 1, 2016

Primary Completion Date

September 22, 2017

Study Completion Date

September 22, 2017

Conditions
Colorectal Neoplasm
Interventions
DRUG

DS-8273a + nivolumab

Nivolumab will be administered at 240 mg intravenously (IV) once every two weeks (Q2W) over 30 (± 5) minutes (on Days 1 and 15 of each cycle of 28 days). DS-8273a will be administered \[90 (± 15) minutes on Day 1 of Cycle 1, and 60 (± 15) minutes in subsequent infusions\] after the end of the nivolumab infusion in ascending doses up to 1200 mg IV Q2W. The regimen is adjusted based on injection site reactions or adverse events. Additional dose combinations may be considered based on the assessment of safety, primary pharmacodynamic (PDy) effects, and preliminary anti-tumor activities.

Trial Locations (4)

20007

Georgetown University Medical Center, Washington D.C.

49503

South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids

78229

South Texas Accelerated Research Therapeutics, LLC (START), San Antonio

77030-4009

MD Anderson Cancer Center, Houston

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY