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
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
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).
Sequential
CBI-1214
Biological/VaccineCBI-1214 is a bispecific T cell engager that binds to LY6G6D and CD3. It is designed to link the patients T cells to cancer cells and to mediate tumor cell killing. LY6G6D is an emerging target specifically expressed on malignant colorectal cancer cells.
To evaluate the safety and tolerability of CBI-1214 at increasing dose levels and optimized dose levels in participants with advanced or metastatic MSS/MSI-L CRC
Incidence and severity of TEAEs, TRAEs, and TESAEs; changes in vital signs, physical examinations, and clinical laboratory parameters per NCI-CTCAE v5.0.
To determine the MTD and/or OBD and select the recommended dose(s) of CBI-1214 for dose optimization
Incidence of DLTs observed during the first treatment cycle
To characterize the Serum Concentration of CBI-1214.
Serum concentration of CBI-1214 at specified timepoints following a single infusion as well as following repeat infusions.
Overall Response Rate (ORR)
ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Duration of Response (DOR)
Duration of response (DOR), defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Progression Free Survival (PFS)
The time from the date of first dose of study treatment to the first documentation of disease progression as determined by RECIST version 1.1, or death from any cause, whichever occurs first.
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