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 statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCartography Biosciences

About this trial

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

Qualifiers

Participant with MSS/MSI-L CRC, who has exhausted at least one prior line of standard systemic therapy for their current malignancy.

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

Disqualifiers

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 nervous system (CNS) metastatic disease.

Active autoimmune disease that has required systemic treatment within the past 2 years (participants with hormone replacement therapy for adequately controlled endocrinopathy are allowed in the study).

Trial design

Treatments tested in this trial

  • CBI-1214

Treatment groups

80 Participants
are divided into 1 treatment group

Sponsors and collaborators