Advanced Colorectal Cancer, Colon Cancer, Colorectal Cancer, Colorectal Cancer (CRC), Colorectal (Colon or Rectal) Cancer, CRC, Metastatic Colon Cancer
Conditions
Keywords
Oncology, Solid Tumor, Phase 1, First-in-Human, Dose Escalation, Open-Label, T-Cell Engager, TCE, CartographyBio
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
Interventions
BIOLOGICALCBI-1214
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.
Sponsors
Cartography Biosciences
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Approximately 48 months | 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 | Approximately 48 months | Incidence of DLTs observed during the first treatment cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To characterize the Serum Concentration of CBI-1214. | Approximately 48 months | Serum concentration of CBI-1214 at specified timepoints following a single infusion as well as following repeat infusions. |
| Overall Response Rate (ORR) | Approximately 48 months | 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) | Approximately 48 months | 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) | Approximately 48 months | 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 to Response (TTR) | Approximately 48 months | 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. |
| Clinical Benefit Rate (CBR) | Approximately 48 months | 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. |
| Overall Survival (OS) | Approximately 48 months | The time from the date of first dose of study treatment to death from any cause. |
Countries
United States
Contacts
CONTACTStudy Lead
Outcome results
None listed