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
Malignancy
Colon cancer, rectal cancer, colorectal cancer, CRC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
3rd Line or greater
Investigational Agent
Trastuzumab deruxtecan (DS8201)
Drug Class
HER2 targeted antibody
PI
Axel Grothey, MD
Sponsor
Daiichi Sankyo, Inc.
Phase
Status
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
  • Primary- ORR in HER2 3+ or FISH positive
  • Secondary- ORR in other cohorts, DoR, DCR, PFS, OS, safety
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Adenocarcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X