Clinical Trial

INCA033890-303: A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

MOA: INCA33890 is a Fc-silenced, IgG1 bispecific antibody that can simultaneously bind to both PD-1 and TGFβR2.

Key Eligibility Criteria:

• Histologically or cytologically confirmed metastatic colorectal adenocarcinoma not amenable to curative resection
• No prior systemic treatment for unresectable or metastatic CRC
  • Subjects who previously received neoadjuvant and/or adjuvant therapy
• Subjects must have radiographically measurable disease per RECIST v1.1
• Subjects must have availability of results for MSI-H/dMMR status, KRAS mutation status, and BRAF V600E mutation status
  • Subjects with known MSI-H/dMMR status or BRAF V600E mutation are excluded
  • Retrospective MSI and/or MMR status will be assessed centrally
  • Subjects that received treatment with an anti–PD-(L)1, anti–CTLA-4 antibody, or any other drug specifically targeting T-cell costimulation or checkpoint pathways within the past 3 years are excluded