CBI-1214 for Colorectal Cancer

Recruiting at 1 trial location

Overseen By Study Lead

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Cartography Biosciences

Disqualifiers: Organ transplant, CNS metastasis, Autoimmune, Infection, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic MSS/MSI-L colorectal cancer who have already tried at least one standard treatment without success. They should have also used approved targeted therapies and either progressed, not responded, or couldn't tolerate them. Participants must be able to provide a tissue sample from previous tests or agree to a new biopsy.

Inclusion Criteria

I have colorectal cancer that is not highly mutated and have tried at least one standard treatment.

I have been treated with FDA-approved targeted therapies before.

My condition worsened or didn't respond well to targeted treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation and Optimization

Participants will be assigned sequentially to escalating doses of CBI-1214. Once dose escalation is completed, a recommended expansion dose will be proposed for the dose-expansion stage of the trial.

48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 months

What Are the Treatments Tested in This Trial?

Interventions

• CBI-1214

Trial Overview

The study is testing CBI-1214, which is designed to engage T cells in fighting the tumor. It aims to evaluate how safe it is, how well patients can handle it, what happens to the drug in the body (pharmacokinetics), and if it's effective against this type of colorectal cancer.

How Is the Trial Designed?

Group I: Dose escalation and optimization trial of CBI-1214 Experimental Treatment 1 Intervention

Participants will be assigned sequentially to escalating doses of CBI-1214. Once dose escalation is completed, a recommended expansion dose will be proposed for the dose-expansion stage of the trial.

Who Is Running the Clinical Trial?

Cartography Biosciences

Lead Sponsor