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Monoclonal Antibodies
Botensilimab + Balstilimab for Colorectal Cancer
Phase 2
Waitlist Available
Research Sponsored by Agenus Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first study dose (pre-dose and 1 hour post-dose) through up to 2 years
Awards & highlights
Study Summary
This trial tests a new drug to fight colorectal cancer that has not responded to other treatments.
Who is the study for?
This trial is for adults with metastatic colorectal cancer that's unremovable and has worsened after at least one chemotherapy regimen. They must have tried specific standard treatments, be in good physical condition (ECOG 0 or 1), and have a life expectancy of at least 12 weeks. Women should not be pregnant, and men must use contraception if their partners can bear children.Check my eligibility
What is being tested?
The study tests botensilimab alone or combined with balstilimab/standard care in patients with refractory metastatic colorectal cancer. It's an open-label Phase 2 trial to see how well these treatments work, how safe they are, what side effects occur, and how the body processes the drugs.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to botensilimab/balstilimab stimulating the immune system against cancer cells. This could lead to inflammation in various organs, infusion reactions similar to allergic responses during drug administration, fatigue from treatment burden on the body, digestive issues like nausea or diarrhea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first study dose (pre-dose and 1 hour post-dose) through up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first study dose (pre-dose and 1 hour post-dose) through up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
Duration of Response
Number of Participants Experiencing Treatment-emergent Adverse Events
Number of Participants Positive for Balstilimab Anti-drug Antibodies Following Treatment with Balstilimab
+5 moreTrial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Monotherapy Botensilimab Dose 2Experimental Treatment1 Intervention
Participants will receive botensilimab dose 2 given IV.
Group II: Monotherapy Botensilimab Dose 1Experimental Treatment1 Intervention
Participants will receive botensilimab dose 1 given IV.
Group III: Combination Botensilimab Dose 2 plus BalstilimabExperimental Treatment2 Interventions
Participants will receive botensilimab at dose 2 given IV and balstilimab given IV.
Group IV: Combination Botensilimab Dose 1 plus BalstilimabExperimental Treatment2 Interventions
Participants will receive botensilimab at dose 1 given IV and balstilimab given IV.
Group V: Standard of CareActive Control1 Intervention
Participants will receive select standard of care as determined by the investigator.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while targeted therapy focuses on specific molecules involved in cancer growth, such as VEGF or EGFR.
Immunotherapy, including checkpoint inhibitors like Botensilimab (an anti-CTLA-4 antibody), works by enhancing the immune system's ability to recognize and destroy cancer cells. Botensilimab blocks CTLA-4, a protein that downregulates immune responses, thereby boosting T-cell activity against cancer cells.
This is particularly important for colorectal cancer patients as it offers a potential treatment option for those with refractory metastatic disease, where traditional therapies may have failed.
Towards therapeutic vaccines for colorectal carcinoma: a review of clinical trials.
Towards therapeutic vaccines for colorectal carcinoma: a review of clinical trials.
Find a Location
Who is running the clinical trial?
Agenus Inc.Lead Sponsor
52 Previous Clinical Trials
4,555 Total Patients Enrolled
Medical DirectorStudy DirectorAgenus Inc.
2,789 Previous Clinical Trials
8,067,100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an uncontrolled HIV infection.My condition causes fluid buildup in my abdomen that is hard to treat.I have had an organ, stem cell, or bone marrow transplant.I have an active heart condition.I need medication that affects liver enzymes.My tumor is MSI-H/dMMR as confirmed by a test.I am currently experiencing active bleeding symptoms.I have wounds that are not healing.I haven't received growth factors, transfusions, or albumin in the last 14 days.I haven't taken specific drugs recently before starting the trial.I have had a bowel blockage or symptoms of one in the last 3 months.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I don't have any health issues that would affect the study or stop me from participating fully.My organs are working well.I am fully active or can carry out light work.I have had at least one chemotherapy treatment for my cancer that has returned or spread.I have been treated with regorafenib or trifluridine/tipiracil.I have or had lung inflammation or scarring that needed steroids.My colorectal cancer cannot be removed by surgery and has spread.I don't have any other cancers needing treatment or that were active in the last 2 years, except for certain low-risk or treated skin, prostate, or noninvasive cancers.My scans show cancer has spread to my liver.I had a mild or no symptom COVID-19 infection within the last 10 days or a severe one within the last 20 days.My tumor was tested for MSI-H or dMMR status.I haven't taken high-dose steroids or immunosuppressants recently.I have a gut condition that could affect how I absorb medication.My high blood pressure is not controlled by medication.I agree to use effective birth control during and up to 6 months after the study.I have an active hepatitis C infection confirmed by tests.I have brain metastases but meet the specific exceptions.I have received treatments targeting my immune system to fight cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy Botensilimab Dose 2
- Group 2: Monotherapy Botensilimab Dose 1
- Group 3: Standard of Care
- Group 4: Combination Botensilimab Dose 1 plus Balstilimab
- Group 5: Combination Botensilimab Dose 2 plus Balstilimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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