BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases
A Single-Arm, Phase II Study Evaluating Combination Balstilimab Plus Botensilimab With AgenT-797 in Previously Treated Patients With pMMR Metastatic CRC With Liver Metastases
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans, Blood draws, Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Tumor assessments will be performed using CT or MRI at regular intervals to evaluate response per RECIST v1.1."
- "Blood samples will be collected for safety monitoring and exploratory biomarker analyses, including ctDNA and immune profiling."
- "Archival tumor tissue will be collected when available, and on-study biopsies may be obtained to support correlative research."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether balstilimab, botensilimab, and agenT-797 are safe and can shrink tumors. It is for adults with previously treated colon or rectal cancer that has spread to the liver and is MSS/pMMR, meaning its DNA repair system still works. Everyone gets all three drugs; there is no comparison group.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older with colon or rectal cancer that has spread to the liver. If the liver tumors were treated directly before, cancer must still be active there.
- Have at least one tumor that can be measured on scans, including one in the liver.
- Have an approved tumor test showing MSS/pMMR cancer, meaning its DNA repair system still works.
- Have had cancer drug treatment that included fluorouracil, oxaliplatin, and irinotecan, together or separately. Prior treatment with an EGFR blocker or bevacizumab is also needed if suitable and safe for you.
- Be fully active or able to do light work, and be expected to live at least 12 weeks.
- Have blood tests showing that your organs, blood cell levels, and blood clotting meet study limits.
- Be willing and able to sign a form agreeing to join the study.
- Have a negative pregnancy test if you could become pregnant, and agree to use effective birth control during the study.
Who can't join
- Have dMMR/MSI-high cancer, meaning its DNA repair system does not work well; have had immunotherapy; or have had cancer treatment too recently under study rules.
- Have a blocked bowel now, signs it may become blocked, or a blockage within 3 months; or have belly fluid buildup needing frequent drainage or recently increased water pills.
- Have serious heart or blood vessel disease, an abnormal heart rhythm beyond study limits, uncontrolled high blood pressure, too much protein in urine, or another serious uncontrolled health problem.
- Have active or untreated cancer in the brain or its lining, or another cancer needing treatment or active within 2 years, with some exceptions.
- Have an allergy to the study drugs or their ingredients; lung inflammation that needed steroid treatment; a past organ, stem cell, or bone marrow transplant from a donor; or an immune system disease needing treatment.
- Need medicines that weaken the immune system, including steroids above study limits; have an active infection, including HIV, HTLV, hepatitis B or C; or have had COVID-19 too recently under study rules.
- Have wounds that are not healing, active bleeding, uncontrolled thyroid problems, or a mental health or substance use condition that could prevent taking part.
- Have received a live or weakened-virus vaccine within 30 days before treatment or during the study; or be pregnant, breastfeeding, or planning pregnancy during the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
CA
- Scripps Clinic Torrey Pines · La Jolla, CA 92037Darren Sigal Principal Investigator, MD · Study contact · 858-554-8788 · CRSLeadership@scrippshealth.orgMore trials in La Jolla