West Cancer Center

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

NCT04479436

Malignancy

Colon cancer, Rectal Cancer, Colorectal Cancer, CRC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

3rd Line or later

Investigational Agent

U3-1402

Drug Class

HER-3 directed ADC

Sponsor

Daiichi Sankyo, Inc.

Phase

Phase 2

Status

Temporarily On Hold

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

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Adenocarcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized