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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 dose through up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests botensilimab alone or with balstilimab in adults with advanced colorectal cancer who didn't respond to previous chemotherapy. The new drugs aim to enhance the immune system's ability to fight cancer.

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~first dose through up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose through up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate
Secondary study objectives
Duration of Response
Overall Survival
Progression-free Survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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.

Find a Location

Who is running the clinical trial?

Agenus Inc.Lead Sponsor
52 Previous Clinical Trials
4,582 Total Patients Enrolled
Medical DirectorStudy DirectorAgenus Inc.
2,849 Previous Clinical Trials
8,080,646 Total Patients Enrolled

Media Library

Balstilimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05608044 — Phase 2
Colorectal Cancer Research Study Groups: Monotherapy Botensilimab Dose 2, Monotherapy Botensilimab Dose 1, Standard of Care, Combination Botensilimab Dose 1 plus Balstilimab, Combination Botensilimab Dose 2 plus Balstilimab
Colorectal Cancer Clinical Trial 2023: Balstilimab Highlights & Side Effects. Trial Name: NCT05608044 — Phase 2
Balstilimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05608044 — Phase 2
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