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Botensilimab and Balstilimab Optimization in Colorectal Cancer

NCT06268015 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-02-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Leucovorin

400 mg/m2 IV every 2 weeks

DRUG

Fluorouracil

400 mg/m2 IV bolus + 2,400 mg/m2 IV (over 46 hours) every 2 weeks

DRUG

Bevacizumab

5 mg/kg IV every 2 weeks

DRUG

Panitumumab

6 mg/kg IV every 2 weeks

DRUG

Balstilimab

240 mg IV every 2 weeks

DRUG

Oxaliplatin

85 mg/m2 IV every 2 weeks

DRUG

Botensilimab

75 mg IV every 6 weeks for up to 4 doses

Sponsors & Collaborators

  • Gateway for Cancer Research

    collaborator OTHER

  • Agenus Inc.

    collaborator INDUSTRY

  • Nicholas DeVito, MD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2028-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06268015 on ClinicalTrials.gov