What is balstilimab, botensilimab, and agenT-797 studying for metastatic colorectal cancer?

This trial studies whether the combination of balstilimab, botensilimab, and agenT-797 is safe and effective in adults with metastatic colorectal cancer that is microsatellite stable and has spread to the liver. Researchers aim to see how many participants have tumor shrinkage and what side effects occur. The study is led by Dr. Darren Sigal and focuses on improving treatment options for this condition.

Who may be eligible for this metastatic colorectal cancer clinical trial?

Adults 18 years and older with metastatic colorectal cancer that has spread to the liver and is microsatellite stable may be eligible. Participants should have had prior treatment including certain chemotherapy drugs and have good performance status. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic colorectal cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07550088

Phase II Study of Balstilimab, Botensilimab, and agenT-797 Combination Therapy for Adults with Previously Treated Microsatellite Stable Metastatic Colorectal Cancer with Liver Metastases

Led by Darren Sigal, MD · Updated on 2026-08-10

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying adults with previously treated metastatic colorectal cancer that is microsatellite stable pMMR and has spread to the liver. This Phase II trial evaluates the safety and effectiveness of a combination therapy involving balstilimab, botensilimab, and agenT-797. The study aims to determine how many participants experience tumor shrinkage and what side effects may occur with this treatment. Participants will receive balstilimab and botensilimab intravenously in fixed doses on specified days of each 42-day treatment cycle, for up to nine cycles or until disease progression or other reasons for stopping. AgenT-797, a cell therapy, will be administered intravenously on specific days during the first two cycles. All participants receive this combination treatment there is no comparison group. Throughout the study, participants will undergo imaging scans like CT or MRI to assess tumor response, provide blood samples to monitor safety and study biomarkers, and may provide tumor tissue samples. Side effects will be closely monitored. After treatment, participants have follow-up visits to assess survival and safety. The primary outcome measured is the overall response rate based on imaging until progression or up to about 12 months.

CONDITIONS

Brief Title

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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Investigational Immunotherapy Triplet	Current Standard Option
What it is	A combination of three immunotherapies: balstilimab (anti-PD-1 antibody), botensilimab (anti-CTLA-4 antibody), and agenT-797 (allogeneic invariant natural killer T cells), administered intravenously in a specific multi-cycle regimen.	An oral chemotherapy drug made of trifluridine and tipiracil (TAS-102) that is used as a standard treatment for metastatic colorectal cancer, particularly for patients who have stopped responding to other chemotherapies.
Role in trial/clinical pathway	Tested as an investigational approach for patients with pMMR/MSS metastatic colorectal cancer who have liver metastases after standard treatments.	Recommended as a next-line treatment for metastatic colorectal cancer that is refractory to standard chemotherapy, including in those with pMMR/MSS tumors and liver metastases.
Primary use in this setting	Being studied as a novel treatment option to assess tumor response and progression delay in adults with previously treated pMMR/MSS metastatic colorectal cancer involving the liver.	Standard-of-care medication used to improve survival and control disease progression in metastatic colorectal cancer after standard regimens fail.
How it is given or performed	Balstilimab 240 mg is given by IV infusion on Days 1, 15, 29 of 42-day cycles (up to 9 cycles); botensilimab 75 mg IV is administered on Day 1 of Cycles 1–4; agenT-797 cells are infused IV on Day 1 of Cycle 1 and Day 15 of Cycle 2.	TAS-102 is taken by mouth as pills usually twice daily on days 1-5 and 8-12 of each 28-day cycle.
Evidence and maturity of clinical data	Effectiveness and safety in this setting are under investigation, and no mature published outcome data are yet available for this triplet combination in pMMR/MSS mCRC.	Supported by phase 3 clinical trial evidence in refractory metastatic colorectal cancer, demonstrating improved overall survival and disease control in heavily pretreated patients.
Important limitations	No comparative arm; findings may not be generalizable beyond the trial cohort. Safety, long-term outcomes, and benefit over current standard treatments remain to be established in future studies.	Disease control is often temporary; most patients will eventually progress, and side effects such as low white blood cell counts are common.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults 18 years or older with metastatic colorectal cancer that has spread to the liver
At least one measurable tumor lesion including one in the liver
Tumor confirmed as microsatellite stable (MSS) or proficient mismatch repair (pMMR) by FDA-approved test
Received at least one prior systemic therapy including fluorouracil, oxaliplatin, or irinotecan
ECOG performance status of 0 or 1 and life expectancy of at least 12 weeks
Adequate organ and marrow function as defined by blood counts and liver/kidney tests
Willing and able to provide informed consent
Negative pregnancy test for women of childbearing potential
Agreement to use effective contraception during the study

You will not qualify if you...

Tumor is deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-high)
Prior treatment with PD-1, PD-L1, CTLA-4 inhibitors, or other immunotherapy
Evidence of bowel obstruction or recent obstruction within 3 months
Refractory ascites needing frequent drainage or recent increased diuretics
Significant cardiovascular disease or prolonged QTc interval
Active or untreated brain metastases or leptomeningeal disease
Other active cancers needing treatment or recent within 2 years (with exceptions)
Recent prior anti-cancer therapy within specified washout periods
Known allergy to study drugs or ingredients
History or active interstitial lung disease requiring steroids
Prior allogeneic organ, stem cell, or bone marrow transplant
Active or recent autoimmune disease needing systemic treatment
Need for systemic steroids or immunosuppressants within defined timeframes
Active infections like HIV, hepatitis B or C, or others needing treatment
Recent COVID-19 infection within protocol-defined timeframe
Uncontrolled hypertension, significant proteinuria, or other serious medical conditions
Non-healing wounds, active bleeding, or uncontrolled thyroid problems
Psychiatric or substance use disorders interfering with participation
Recent live or attenuated vaccines within 30 days before and during study
Pregnant or breastfeeding women or planning pregnancy during the study

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to approximately 12 months

Participants receive the combination of balstilimab, botensilimab, and agenT-797 in repeating 42-day cycles for up to nine cycles or until disease progression or other reasons for stopping.

Multiple visits during each 42-day cycle for drug administration and monitoring

Follow-up

Duration - Duration varies by participant

After treatment ends, participants are monitored for safety and survival at regular intervals.

Regular follow-up visits