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

Conditions

• Colorectal Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• DS-8273a + nivolumab — DRUG
  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.

Study Details

This trial is being performed in two parts: Dose Escalation and Dose Expansion. The primary objective for the Dose Escalation part is to determine the safety and tolerability at different doses of DS-8273a administered in combination with nivolumab and to identify the dose combination for the Dose Expansion cohort in subjects with mismatch repair (MMR)-proficient advanced colorectal cancer. The primary objectives for the Dose Expansion part are: * To further evaluate the safety and tolerability of DS-8273a administered at the selected dose in combination with nivolumab in subjects with MMR-proficient advanced colorectal cancer * To evaluate preliminary anti-tumor activity of DS-8273a plus nivolumab administered at the selected dose in subjects with MMR-proficient advanced colorectal cancer

Key Dates

Start date

Dec 1, 2016

Status verified

Sep 2017

Primary completion

Sep 22, 2017

Completion

Sep 22, 2017

Study Design

Enrollment

4 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: DS-8273a + nivolumab
  Participants will receive their treatment dose until discontinuation for any reason, or trial completion, within two years

Primary Outcome Measure

Dose Escalation Part: Number of Participants with Dose-Limiting Toxicities (DLT) [ Time Frame: During the first treatment cycle (28 days) ]

Locations (4)

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