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BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases

NCT07550088 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-04-24

No results posted yet for this study

Summary

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

Conditions

  • Colorectal Cancer Metastatic

Interventions

DRUG

Balstilimab (BAL)

Administered at a fixed dose of 240mg intravenously (IV) on Days 1, 15, 29 of each 42-day cycle, for up to 9 cycles.

DRUG

Botensilimab (BOT)

Administered at a fixed dose of 75mg IV on Day 1 of Cycles 1 through 4. In the event of protocol-defined toxicity, the dose may be reduced to 50mg IV per protocol defined criteria.

DRUG

agenT-797

Administered at a dose of 1.4 x 107 cells/kg IV on Day 1 of Cycle 1 and Day 15 of Cycle 2.

Sponsors & Collaborators

  • Scripps Health

    collaborator OTHER

  • Darren Sigal, MD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-09-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07550088 on ClinicalTrials.gov