Recruiting
Phase 2

Balstilimab, Botensilimab, AgenT-797

Sponsor:

Darren Sigal, MD

Code:

NCT07550088

Conditions

Colorectal Cancer Metastatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Balstilimab (BAL)

Botensilimab (BOT)

agenT-797

Study Details

Brief 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

Study ID

NCT07550088

Start date

Jun 10, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults ≥18 years of age with histologically confirmed metastatic colorectal cancer with liver metastases, including evidence of active liver disease if previously treated locally
  • At least one measurable lesion per RECIST v1.1, with ≥1 target lesion in the liver
  • Tumor confirmed as microsatellite stable (MSS)/proficient mismatch repair (pMMR) per a FDA-approved assay (Caris MI Cancer Seek®, FoundationOne® CDx, or Tempus xT CDx).
  • Received ≥1 prior line of systemic therapy including fluorouracil, oxaliplatin, and irinotecan (not necessarily in combination), and prior EGFR inhibitor or bevacizumab if eligible, unless contraindicated
  • ECOG performance status 0-1 and life expectancy ≥12 weeks
  • Adequate organ and marrow function:

  • ANC ≥1.5 × 10⁹/L
  • Platelets ≥100 × 10⁹/L
  • Hemoglobin ≥ 9 g/dL
  • AST/ALT ≤2.5 × ULN
  • Total bilirubin ≤1.5 × ULN
  • Creatinine clearance ≥ 40 mL/min, as measured or calculated per local institutional standards.
  • Albumin ≥3 g/dL
  • PT/PTT ≤1.5 × ULN
  • Willing and able to provide written informed consent
  • Negative pregnancy test for women of childbearing potential
  • Agreement to use effective contraception during study participation

Exclusion Criteria:

  • Tumor is dMMR/MSI-high
  • Prior treatment with PD-1, PD-L1, CTLA-4 inhibitors, or other immunotherapy agents
  • Evidence of bowel obstruction, impending obstruction, or recent obstruction (within 3 months)
  • Refractory ascites requiring frequent paracentesis or recent escalation of diuretics
  • Clinically significant cardiovascular disease (e.g., recent myocardial infarction or stroke, unstable angina, NYHA class ≥III heart failure, uncontrolled arrhythmias) or QTc >480 ms
  • Active or untreated brain metastases or leptomeningeal disease
  • Concurrent malignancy requiring treatment or active within 2 years (with protocol-specified exceptions)
  • Receipt of prior anti-cancer therapy within protocol-defined washout periods, including:

  • Cytotoxic, targeted therapy or other investigational therapy within 3 weeks.
  • Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar therapy, within 4 weeks, or 5 half-lives, whichever is shorter.
  • Small molecules/tyrosine kinase inhibitors within 2 weeks or less than 5 circulating half-lives of investigational drug.
  • Known hypersensitivity to study drugs or excipients
  • History of or active interstitial lung disease or pneumonitis requiring systemic steroids
  • Prior allogeneic transplant (organ, stem cell, or bone marrow)
  • Active or recent autoimmune disease requiring systemic treatment
  • Requirement for systemic corticosteroids (>10 mg prednisone equivalent) or other immunosuppressive therapy within defined windows
  • Active infection, including HIV, HTLV, HBV, HCV, or other infections requiring systemic therapy
  • Recent SARS-CoV-2 infection within protocol-defined timeframe
  • Uncontrolled hypertension, significant proteinuria (UPCR ≥1 g/g), or other clinically significant uncontrolled medical conditions
  • Non-healing wounds, active bleeding, or uncontrolled thyroid dysfunction
  • Psychiatric or substance use disorders that may interfere with study participation
  • Receipt of live or attenuated vaccines within 30 days prior to treatment and while participating in the study
  • Pregnant or breastfeeding women, or those planning pregnancy during the study

Study Design

Enrollment

17 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment arm

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

Interventions

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.

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.

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.

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). ]

Central Contacts and Locations

Locations

Scripps Clinic Torrey Pines

Recruiting

La Jolla, California, United States, 92037

Contacts

Darren Sigal Principal Investigator, MD

858-554-8788CRSLeadership@scrippshealth.org

More Information

Sponsor

Darren Sigal, MD

Last update posted

Aug 10, 2026

Last verified

Apr, 2026

Keywords

  • Metastatic Colorectal Cancer
  • pMMR Colorectal Cancer
  • Liver Metastases
  • Immunotherapy
  • Checkpoint Inhibitor
  • Anti-PD-1
  • Anti-CTLA-4
  • iNKT Cell Therapy
  • Balstilimab
  • Botensilimab
  • agenT-797
  • MSS Colorectal Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Darren Sigal, MD on 2026-08-10.