Botensilimab
Clinical Trials Overview
17 trials found
About Botensilimab
Botensilimab is a novel Fc-enhanced anti-CTLA-4 monoclonal antibody designed for cancer immunotherapy. In colorectal cancer treatment, it is being combined with the anti-PD-1 antibody balstilimab in both localized and metastatic settings. The drug shows activity across different molecular subtypes including microsatellite stable (MSS) and microsatellite instability-high (MSI-H) tumors, and is being tested in combination with standard chemotherapy regimens like FOLFOX.
Category
Immunotherapy
Brand Name
Not yet branded
Mechanism
Botensilimab blocks the CTLA-4 receptor on T cells, preventing inhibitory signals that normally suppress immune responses against cancer cells. Its enhanced Fc region is engineered to improve antibody-dependent cellular cytotoxicity and potentially deplete regulatory T cells in the tumor microenvironment, distinguishing it from conventional CTLA-4 inhibitors.
Efficacy Data by Mutation
Response rates and survival outcomes by patient molecular profile
MSS pMMR
Level 2B
24%
ORR
n=101
Sample
MSS pMMR
Level 2B
22%
ORR
4.2m
PFS
14.5m
OS
n=155
Sample
MSS pMMR
Level 2B
17%
ORR
n=101
Sample
MSS Microsatellite Stable
Level 2B
17%
ORR
n=101
Sample
17
Total Trials
9
Recruiting
5
Active
1
Completed
2,359
Total Enrollment
10
Countries
med_trials_trend_title
Number of trials started per year
med_trials_trend_up
med_trials_active_sites
Recruiting sites
10 countries
Phase:
NCT07128355
Early Phase 1
Recruiting
15 patients
Medications:
Balstilimab
Botensilimab
This is a single-arm pilot feasibility study evaluating the combination of Botensilimab and Balstilimab with Radiation Therapy (RT) in Non-Microsatellite Instability High (MSI-H) or Proficient Mismatch Repair (pMMR) chemorefractory colorectal cancer ...
United States
NCT07152821
Phase 3
Recruiting
834 patients
Medications:
Balstilimab
Botensilimab
This study is being done to answer the main question of: Do patients with colorectal cancer that cannot be removed by surgery, that is treated with two new immunotherapy drugs, botensilimab and balstilimab, live longer? Other important questions incl...
Canada
NCT07227636
Phase 2
Recruiting
284 patients
Medications:
Balstilimab
Botensilimab
The researchers are doing this study to find out whether the combination of botensilimab and balstilimab (BOT/BAL), followed by balstilimab alone, is an effective treatment for people with microsatellite stable (MSS) colorectal cancer or colorectal l...
United States
NCT06411691
Phase 1
Recruiting
54 patients
Medications:
Balstilimab
Botensilimab
Phase 1b study evaluating the efficacy and immune response to a synthetic long peptide mutant KRAS vaccine (SPL mKRASvax) combined with Balstilimab and Botensilimab for unresectable or metastatic mismatch repair-proficient (MMR-p) colorectal cancer (...
United States
NCT06780787
Phase 2
Recruiting
26 patients
This phase II trial tests how well fluorouracil, oxaliplatin and leucovorin calcium (folinic acid) (FOLFOX) with botensilimab and balstilimab given before surgery (neoadjuvant) works in treating patients with rectal adenocarcinoma that has not spread...
United States
NCT06843434
Phase 2
Recruiting
40 patients
Medications:
Balstilimab
Botensilimab
The purpose of this study is to find out whether the combination of botensilimab and balstilimab (BOT/BAL) is a safe and effective treatment that causes few or mild side effects for people with mismatch repair proficient (MMRp)/microsatellite stable ...
United States
NCT06336902
Phase 1
Recruiting
15 patients
Medications:
Balstilimab
Botensilimab
This phase Ib trial tests the safety, side effects, and effectiveness of botensilimab, and balstilimab in combination with a fasting mimicking diet and high dose vitamin C in treating patients with KRAS-mutant metastatic colorectal cancer. Botensilim...
United States
NCT06300463
Phase 2
Recruiting
24 patients
The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The m...
United States
NCT05845450
Phase 2
Recruiting
197 patients
Medications:
Amivantamab
Balstilimab
Botensilimab
Durvalumab
Nivolumab
Panitumumab
Sotorasib
Trastuzumab deruxtecan
Vorbipiprant
This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration. The study aims to test the activity of specific targeted agents/c...
Italy
NCT06268015
Phase 2
Active
16 patients
This is a single-arm, interventional, pilot clinical trial. Fifteen evaluable patients will have tumor-informed ctDNA testing at baseline and start botensilimab and balstilimab treatment. They will receive botensilimab and balstilimab in 6-week cycle...
United States
NCT05672316
Phase 1
Active
28 patients
This phase I/II trial tests how well botensilimab, balstilimab, and regorafenib works in treating patients with microsatellite stable colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic...
United States
NCT05627635
Phase 1
Active
20 patients
This phase I/II trial tests the safety, side effects, best dose, and efficacy of FOLFOX and bevacizumab in combination with botensilimab and balstilimab (3B-FOLFOX) in treating patients with microsatellite stable (MSS) colorectal cancer that has spre...
United States
NCT05608044
Phase 2
Active
234 patients
Medications:
Balstilimab
Botensilimab
This is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab or standard-of-care treatments in participants with refr...
United States, Belgium, Brazil, France, Georgia, Italy, Russia, Spain
NCT03860272
Phase 1
Active
499 patients
Medications:
Balstilimab
Botensilimab
This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte an...
United States, United Kingdom
NCT07551596
Phase 2
Not yet recruiting
20 patients
Medications:
Balstilimab
Botensilimab
This phase II trial tests the effect of the botensilimab in combination with balstilimab in treating patients with stage II/III colorectal adenocarcinoma with detectable circulating tumor (ct) deoxyribonucleic acid (DNA) in the blood. Immunotherapy w...
NCT07550088
Phase 2
Not yet recruiting
17 patients
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...
United States
NCT05571293
Phase 2
Completed
36 patients
Medications:
Balstilimab
Botensilimab
This is a pilot study to see whether a combination of two investigational drugs that target the immune system can be given to people with colorectal cancer before surgically removing the tumor. This study is also being done to see what side effects t...
United States