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Colorectal: Metastatic: 3rd Line or Later: U3-1402-A202

A Multi-Center, Open-Label, Phase 2 Study to Evaluate Safety and Efficacy of U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer (CRC)

Title
Daiichi Sankyo U31402-A-U202 (late line CRC)
Study Title

A Multi-Center, Open-Label, Phase 2 Study to Evaluate Safety and Efficacy of U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer (CRC)

Site Link
Malignancy
Colon cancer, Rectal Cancer, Colorectal Cancer, CRC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
3rd Line or later
Investigational Agent
U3-1402
Drug Class
HER-3 directed ADC
PI
Axel Grothey, MD
Sponsor
Daiichi Sankyo, Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Pathological/histological confirmation of advanced or metastatic colon or rectal adenocarcinoma
  • Must be resistant, refractory, or intolerant to at least 2 prior lines of tx, that must include all of the following agents:
    • Fluoropyrimidine
    • Irinotecan
    • Platinum agents (oxaliplatin)
    • Anti EGFR agent if clinically indicated (RAS/BRAF wt)
    • Anti-VEGF agent (bevacizumab) unless contraindicated
    • IO therapy if clinically indicated (MSI-h)
  • MEasurable disease
  • ECOG PS 0-1
  • No history of interstitial lung disease
  • No severe pulmonary compromise
  • No steroids at >10mg prednisone daily or equivalent
  • No clinically active CNS disease
  • No prior treatment with anti-HER3 antibody or ADC containing topoisomerase I inhibitor
  • No other cancers within 3 years unless curatively treated
  • No known HBV/HCV
Objective
  • Primary
    • ORR
  • Secondary
    • DOR
    • ORR by investigator
    • DCR
    • TTR
    • PFS
    • OS
    • AEs
    • PK
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Adenocarcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X