Balstilimab + Botensilimab + agenT-797 for Colorectal Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Darren Sigal, MD

Must not be taking: Immunotherapy, Corticosteroids

Disqualifiers: Brain metastases, Cardiovascular disease, Autoimmune disease, Active infection, Recent cancer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 54 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn whether the combination of balstilimab, botensilimab, and agenT-797 is safe and effective in treating adults with previously treated metastatic colorectal cancer that is microsatellite stable (pMMR) and has spread to the liver.

The main questions it aims to answer are:

* What proportion of participants experience tumor shrinkage (objective response rate) based on imaging assessments?

* What side effects occur with this combination treatment, including immune-related and cytokine-related reactions?

All participants in this study will receive the combination treatment. There is no comparison group.

Participants will:

* Receive balstilimab, botensilimab, and agenT-797 in repeating 42-day treatment cycles

* Undergo imaging scans (such as CT or MRI) to assess tumor response

* Have blood samples collected to monitor safety and evaluate biomarkers

* Provide tumor tissue samples for research

* Be monitored for side effects throughout the study

* Participate in follow-up visits to assess survival after treatment completion

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing and able to provide written informed consent

Agreement to use effective contraception during study participation

Negative pregnancy test for women of childbearing potential

Exclusion Criteria

Active or recent autoimmune disease requiring systemic treatment

Known hypersensitivity to study drugs or excipients

My tumor is dMMR or MSI-high.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive balstilimab, botensilimab, and agenT-797 in repeating 42-day treatment cycles for up to nine cycles

Up to 54 weeks

Regular visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, including survival assessments

12 months

Regular follow-up visits to assess survival

What Are the Treatments Tested in This Trial?

Interventions

• agenT-797
• Balstilimab
• Botensilimab

How Is the Trial Designed?

Group I: Treatment arm Experimental Treatment 3 Interventions

balstilimab (BAL) + botensilimab (BOT) + agenT-797

Who Is Running the Clinical Trial?

Darren Sigal, MD

Lead Sponsor

Scripps Health

Collaborator

Trials

59

Recruited

43,400+