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 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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