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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
CBI-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.
NEXT Oncology
San Antonio, Texas, United States
RECRUITINGNEXT Oncology
Fairfax, Virginia, United States
RECRUITINGTo 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.
Time frame: Approximately 48 months
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
Time frame: Approximately 48 months
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.
Time frame: Approximately 48 months
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)
Time frame: Approximately 48 months
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
Time frame: Approximately 48 months
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.
Time frame: Approximately 48 months
Time to Response (TTR)
The time from the date of first dose of study treatment to the first documented evidence of objective tumor response (Complete Response \[CR\] or Partial Response \[PR\]) as assessed per RECIST version 1.1.
Time frame: Approximately 48 months
Clinical Benefit Rate (CBR)
The proportion of subjects who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) lasting for a minimum prespecified duration (e.g., ≥12 or ≥16 weeks) as determined by RECIST version 1.1.
Time frame: Approximately 48 months
Overall Survival (OS)
The time from the date of first dose of study treatment to death from any cause.
Time frame: Approximately 48 months
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