A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer
Trial Parameters
Brief Summary
This study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or metastatic Microsatellite Stable (MSS)/Microsatellite Instability Low (MSI-L) Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Participant with MSS/MSI-L CRC, who has exhausted at least one prior line of standard systemic therapy for their current malignancy. * Participant with genomic aberrations, including but not limited to BRAFV600E mutations and HER2 amplifications, for which FDA-approved targeted therapies are available, must: * Have received prior treatment with applicable FDA-approved targeted therapies AND * Either have experienced disease progression, be refractory, or be intolerant to directed molecular therapy. * Participant able to provide archival tissue sample or fresh biopsy tissue sample Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Participant whose CRC tumor tissues have been identified as dMMR or MSI-H * Known history of solid organ or tissue transplant; history of interstitial lung disease or non-infectious pneumonitis. * Untreated central nervou