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

Part of paid clinical trials in La Jolla, California.

Sponsor
Darren Sigal, MD
Study ID
NCT07550088
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Balstilimab (BAL) — DRUG
    Administered at a fixed dose of 240mg intravenously (IV) on Days 1, 15, 29 of each 42-day cycle, for up to 9 cycles.
  • Botensilimab (BOT) — DRUG
    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.
  • agenT-797 — DRUG
    Administered at a dose of 1.4 x 107 cells/kg IV on Day 1 of Cycle 1 and Day 15 of Cycle 2.

Study Details

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

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
17 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    balstilimab (BAL) + botensilimab (BOT) + agenT-797

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: From enrollment until first documented disease progression or end of study treatment (up to approximately 12 months). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Scripps Clinic Torrey PinesLa JollaCalifornia92037
Darren Sigal Principal Investigator, MD
[email protected]

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By research site
Scripps Clinic Torrey Pines· La Jolla, CA

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