Botensilimab and Balstilimab Optimization in Colorectal Cancer

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Nicholas DeVito, MD
Study ID
NCT06268015
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Botensilimab — DRUG
    75 mg IV every 6 weeks for up to 4 doses
  • Balstilimab — DRUG
    240 mg IV every 2 weeks
  • Oxaliplatin — DRUG
    85 mg/m2 IV every 2 weeks
  • Leucovorin — DRUG
    400 mg/m2 IV every 2 weeks
  • Fluorouracil — DRUG
    400 mg/m2 IV bolus + 2,400 mg/m2 IV (over 46 hours) every 2 weeks
  • Bevacizumab — DRUG
    5 mg/kg IV every 2 weeks
  • Panitumumab — DRUG
    6 mg/kg IV every 2 weeks

Study Details

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 cycles until progression, after which mFOLFOX6 and bevacizumab or panitumumab will be added to the regimen. Subjects will have safety testing at baseline and every two weeks while on study drug. Study treatment with botensilimab and balstilimab, mFOLFOX6, and bevacizumab or panitumumab will be continued until radiographic or clinical progression, toxicity, or patient withdrawal. Subjects will have one safety follow up visit 30 days after the last treatment and will be followed for survival every 12 weeks for up to 2 years.

Key Dates

Start date
Nov 18, 2024
Status verified
Jan 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    botensilimab + balstilimab until disease progression, then botensilimab + balstilimab + mFOLFOX6 (leucovorin, fluorouracil, oxaliplatin) + {bevacizumab or panitumumab}

Primary Outcome Measure

Disease control rate based on iRECIST at second restaging scan [ Time Frame: 24 weeks after screening ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Duke University· Durham, NC

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