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COLORECTAL: METASTATIC: RAS/RAF wt: 3rd line: DS8201-A-J203

A phase 2, multicenter, open-label study of DS-8201A in subjects wtih HER2- expressing advanced colorectal cancer

Title

Daiichi Sankyo DS8201-A-J203 (COLORECTAL)

Study Title

A phase 2, multicenter, open-label study of DS-8201A in subjects wtih HER2- expressing advanced colorectal cancer

Site Link

NCT03384940

Malignancy

Colon cancer, rectal cancer, colorectal cancer, CRC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

3rd Line or greater

Investigational Agent

Trastuzumab deruxtecan (DS8201)

Drug Class

HER2 targeted antibody

Axel Grothey, MD

Sponsor

Daiichi Sankyo, Inc.

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Metastatic or unresectable colorectal cancer.
KRAS, NRAS, and BRAF wt
Must have at least 1+ on HER2 testing by central vendor
Able to provide archival tumor sample
ECOG PS 0-1
LVEF > or = 50%
No surgery or radiation within 4 weeks prior to enrollment
No MI within 6 months
No symptomatic CHF or elevated troponins within 4 weeks
No corneal disease
No active CNS mets
No other malignancy within 3 years (except solid tumors curatively treated, in situ dz, or non-melanoma skin cancer)
No known HIV/HBV/HC

Objective

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Adenocarcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized