A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
NCT ID: NCT05608044
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
234 participants
INTERVENTIONAL
2022-11-30
2029-09-30
Brief Summary
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Detailed Description
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This study will consist of 5 cohorts. In the first and second cohorts, participants will receive 1 of 2 different doses of botensilimab intravenously (IV) and balstilimab IV. In the third and fourth cohorts, participants will receive 1 of 2 different doses of botensilimab. In the fifth cohort, participants will receive standard of care consisting of the investigator's choice of regorafenib or trifluridine and tipiracil.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combination Botensilimab Dose 1 plus Balstilimab
Participants will receive botensilimab at dose 1 given IV and balstilimab given IV.
Botensilimab
An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.
Balstilimab
An anti-programmed death (ligand) 1 \[PD-(L)1\] monoclonal antibody.
Combination Botensilimab Dose 2 plus Balstilimab
Participants will receive botensilimab at dose 2 given IV and balstilimab given IV.
Botensilimab
An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.
Balstilimab
An anti-programmed death (ligand) 1 \[PD-(L)1\] monoclonal antibody.
Monotherapy Botensilimab Dose 1
Participants will receive botensilimab dose 1 given IV.
Botensilimab
An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.
Monotherapy Botensilimab Dose 2
Participants will receive botensilimab dose 2 given IV.
Botensilimab
An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.
Standard of Care
Participants will receive select standard of care as determined by the investigator.
Standard of Care
Regorafenib or trifluridine and tipiracil.
Interventions
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Botensilimab
An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.
Balstilimab
An anti-programmed death (ligand) 1 \[PD-(L)1\] monoclonal antibody.
Standard of Care
Regorafenib or trifluridine and tipiracil.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The tumor must have been assessed for microsatellite instability high (MSI-H) or deficient mismatch repair (dMMR) status per a standard local testing method.
3. Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.
4. Must have received at least 1 prior chemotherapy regimen for metastatic or recurrent CRC as follows where approved and locally available in the country of randomization:
1. Standard chemotherapy/therapy including all of the following agents (if eligible and no contraindication): a fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab or biosimilars, an anti-epidermal growth factor receptor antibody (cetuximab or panitumumab), and v-raf murine sarcoma viral oncogene homolog B1 inhibitor/BRAF (encorafenib), if applicable.
2. Participants must have progressed while receiving or within 3 months of the last administration of their last line of standard therapy or be unable to tolerate any of these standard treatments.
3. Participants who received adjuvant chemotherapy and had recurrence during or within 6 months of completion of the adjuvant chemotherapy can count this as a line of therapy.
5. Measurable disease on baseline imaging per RECIST 1.1.
6. Life expectancy ≥ 12 weeks.
7. Eastern Cooperative Oncology Group performance status of 0 or 1.
8. Adequate organ function.
9. Women of childbearing potential must have a negative serum pregnancy test at screening and prior to study drug administration.
10. Male participants with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study, starting with the Screening visit through 2-6 months, depending upon assigned study treatment. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
11. No growth factor support, transfusions, or albumin administration within 14 days of randomization of study treatment.
Exclusion Criteria
2. Received programmed cell death protein 1, PD-(L)1, or CTLA-4 therapies including any immune checkpoint inhibitor or experimental immunologic agents.
3. Received regorafenib or trifluridine/tipiracil as prior therapy(ies).
4. Partial or complete bowel obstruction within the last 3 months, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction.
5. Refractory ascites.
6. Liver metastases by computed tomography or magnetic resonance imaging. Note: Participants with definitively treated liver metastases (this includes surgical resection, including microwave or radiofrequency ablation, or stereotactic body radiation therapy, but not yttrium-90 or chemotherapy alone) may be eligible if they were treated at least 6 months prior to enrollment with no evidence of metastatic disease in the liver on subsequent imaging.
7. Clinically significant (that is, active) cardiovascular disease.
8. Active brain metastases or leptomeningeal metastases with certain exceptions.
9. Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment. Participants with history of prior early-stage basal/squamous cell skin cancer, low-risk prostate cancer eligible for active surveillance, or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible.
10. Treatment with one of the following classes of drugs within the delineated time window prior to Cycle 1 Day 1 (C1D1):
1. Cytotoxic, targeted therapy or other investigational therapy within 3 weeks.
2. Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar therapy, within 4 weeks, or 5 half-lives, whichever is shorter.
3. Small molecule/tyrosine kinase inhibitors within 2 weeks or less than 5 circulating half-lives of investigational drug.
11. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
12. Any evidence of current interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids.
13. History of allogeneic organ transplant, stem cell transplant, or bone marrow transplant.
14. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
15. Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 milligrams \[mg\] daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.
16. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (that is, with use of disease-modifying agents or immunosuppressive drugs).
17. History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
18. Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to C1D1.
19. Uncontrolled infection with human immunodeficiency virus.
20. Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection.
21. Known active hepatitis C virus as determined by positive serology and confirmed by polymerase chain reaction.
22. Has urine protein ≥ 1 gram/24 hour.
23. Uncontrolled hypertension: systolic pressure ≥ 150 millimeters of mercury (mmHg) or diastolic pressure ≥ 90 mmHg on repeated measurements that cannot be managed by standard antihypertension medications ≤ 28 days before the first dose of study drug(s).
24. Participants who require treatment with strong cytochrome P450 3A4 inducers or inhibitors.
25. Has presence of gastrointestinal condition, for example, malabsorption, that might affect the absorption of study drug(s).
26. Non-healing wound(s).
27. Symptomatic active bleeding.
18 Years
ALL
No
Sponsors
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Agenus Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Agenus Inc.
Locations
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HonorHealth Research Institute
Scottsdale, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
Keck School of Medicine of the University of Southern California
Los Angeles, California, United States
Rocky Mountain Cancer Center - Aurora
Aurora, Colorado, United States
University of Colorado
Denver, Colorado, United States
Medical Oncology Hematology Consultants
Newark, Delaware, United States
Florida Cancer Specialists and Research Institute - Lake Mary
Lake Mary, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Atlantic Health System - Morristown Medical Center
Morristown, New Jersey, United States
Weill Cornell Medicine
New York, New York, United States
Mount Sinai Hospital - New York
New York, New York, United States
Memorial Sloan Kettering
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Earle A. Chiles Research Institute - Robert W. Franz Cancer Center - Providence Cancer Institute
Portland, Oregon, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
Lifespan Clinical Research Center/Cancer Institute (Providence Rhode Island)
East Providence, Rhode Island, United States
Tennessee Oncology Nashville (Sarah Cannon)
Nashville, Tennessee, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, United States
Texas Oncology - Austin Midtown
Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
MDACC
Houston, Texas, United States
Virginia Cancer Specialists/NEXT Virginia
Fairfax, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Northwest Cancer Center Specialists - Vancouver Cancer Center - Compass Oncology Vancouver
Vancouver, Washington, United States
Antwerp University Hospital (UZA)
Edegem, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho
Jaú, São Paulo, Brazil
Hospital Sirio Libanes Brasilia
Brasília, , Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia
Ijuí, , Brazil
High Technology Hospital Medcenter Ltd
Batumi, , Georgia
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Porto Alegre, , Brazil
Instituto Sul Mineiro de Oncologia - ONCOMINAS
Pouso Alegre, , Brazil
Instituto Americas
Rio de Janeiro, , Brazil
Hospital A.C. Camargo Cancer Center
São Paulo, , Brazil
Centro Paulista de Oncologia
São Paulo, , Brazil
Service d'Oncologie Medicale - CHRU Besancon
Besançon, , France
Institut Paoli-Calmettes
Marseille, , France
Hôpital Saint Antoine/AP-HP Hopital Saint Antoine (Pierre and Marie Curie University)
Paris, , France
CHU Poitiers - Pole Regional de Cancerologie de Poitiers (PRC)
Poitiers, , France
Unversite Paris-Saclay Gustave Roussy Cancer Center Campus Paris
Villejuif, , France
Innova LLC
Tbilisi, , Georgia
Tbilisi Central Hospital Ltd
Tbilisi, , Georgia
Fondazione IRCCS Instituto Nazionale dei Tumori
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Istituto Oncologico Veneto-I.R.C.C.S. - Ospedale Busonera
Padua, , Italy
Regional State Budgetary Institution of Healthcare"Altai Regional Oncology Dispensary"
Barnaul, , Russia
Limited Liability Company "EVIMED"
Chelyabinsk, , Russia
Napalkov SBHI "Saint-Petersburg clinical scientific and practical center for specialised types of medical care (oncological)
Saint Petersburg, , Russia
State Budgetary Institution of Health Care "Clinical Oncological Dispensary No. 1" of the Ministry of Health of the Krasnodar region
Krasnodar, , Russia
Regional Budgetary Healthcare Institution "Kursk Oncological Research and Clinical Center named after G. E. Ostroverkhov"
Kursk, , Russia
Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
Saint Petersburg, , Russia
Siberian State Medical University
Tomsk, , Russia
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, , Spain
State Budgetary Institution of Healthcare of the City of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Health of the City of Moscow"
Moscow, , Russia
Clínica Universidad de Navarra - Sede Madrid
Madrid, , Spain
Clínica Universidad de Navarra - Sede Pamplona
Pamplona, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Federal State Autonomous Educational Institution of Higher Education I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation
Moscow, , Russia
Branch office of " Hadassah Medical Ltd"
Moscow, , Russia
Closed Joint Stock Company Medical Center "AVICENNA"
Novosibirsk, , Russia
BHI of the Omsk region "Clinical oncological dispensary"
Omsk, , Russia
"Clinical Hospital "RZD-Medicine" of Saint Petersburg"
Saint Petersburg, , Russia
Federal State Budgetary Institution "National Medical Research Center of Oncology named after N.N.Petrov" of the Ministry of Health of the Russian Federation
Saint Petersburg, , Russia
Countries
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Other Identifiers
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2022-501546-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C-800-25
Identifier Type: -
Identifier Source: org_study_id
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