A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Agenus Inc.
Study ID
NCT05608044
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Botensilimab — DRUG
    An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.
  • Balstilimab — DRUG
    An anti-programmed death (ligand) 1 \[PD-(L)1\] monoclonal antibody.
  • Standard of Care — DRUG
    Regorafenib or trifluridine and tipiracil.

Study Details

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 refractory metastatic colorectal cancer.

Key Dates

Start date
Nov 30, 2022
Status verified
Sep 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2029

Study Design

Enrollment
234 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Botensilimab Dose 1 plus Balstilimab
    Participants will receive botensilimab at dose 1 given IV and balstilimab given IV.
  • Experimental: Combination Botensilimab Dose 2 plus Balstilimab
    Participants will receive botensilimab at dose 2 given IV and balstilimab given IV.
  • Experimental: Monotherapy Botensilimab Dose 1
    Participants will receive botensilimab dose 1 given IV.
  • Experimental: Monotherapy Botensilimab Dose 2
    Participants will receive botensilimab dose 2 given IV.
  • Active Comparator: Standard of Care
    Participants will receive select standard of care as determined by the investigator.

Primary Outcome Measure

Objective Response Rate [ Time Frame: First dose through up to 2 years ]

Locations (26)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258-
City of Hope National Medical CenterDuarteCalifornia91010-
Keck School of Medicine of the University of Southern CaliforniaLos AngelesCalifornia90033-
Rocky Mountain Cancer Center - AuroraAuroraColorado80012-
University of ColoradoDenverColorado80220-
Medical Oncology Hematology ConsultantsNewarkDelaware19713-
Florida Cancer Specialists and Research Institute - Lake MaryLake MaryFlorida32746-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of MichiganAnn ArborMichigan48084-
Atlantic Health System - Morristown Medical CenterMorristownNew Jersey07960-
Memorial Sloan KetteringNew YorkNew York10065-
Mount Sinai Hospital - New YorkNew YorkNew York10029-
Weill Cornell MedicineNew YorkNew York10021-
Cleveland ClinicClevelandOhio44195-
Earle A. Chiles Research Institute - Robert W. Franz Cancer Center - Providence Cancer InstitutePortlandOregon97213-
Oregon Health & Science University (OHSU)PortlandOregon97239-
Lifespan Clinical Research Center/Cancer Institute (Providence Rhode Island)East ProvidenceRhode Island02915-
Tennessee Oncology Nashville (Sarah Cannon)NashvilleTennessee37203-
Vanderbilt University School of MedicineNashvilleTennessee37215-
Texas Oncology - Austin MidtownAustinTexas78705-
Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
MDACCHoustonTexas77030-
Virginia Cancer Specialists/NEXT VirginiaFairfaxVirginia22031-
Swedish Cancer InstituteSeattleWashington98104-
Northwest Cancer Center Specialists - Vancouver Cancer Center - Compass Oncology VancouverVancouverWashington98684-

Find similar trials in Scottsdale, AZ

By research site
HonorHealth Research Institute· Scottsdale, AZCity of Hope National Medical Center· Duarte, CAKeck School of Medicine of the University of Southern California· Los Angeles, CARocky Mountain Cancer Center - Aurora· Aurora, COUniversity of Colorado· Denver, COMedical Oncology Hematology Consultants· Newark, DE

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