Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05672316
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Colorectal Adenocarcinoma
  • Advanced Microsatellite Stable Colorectal Carcinoma
  • Metastatic Colorectal Adenocarcinoma
  • Metastatic Microsatellite Stable Colorectal Carcinoma
  • Stage III Colorectal Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Balstilimab — BIOLOGICAL
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Botensilimab — BIOLOGICAL
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Regorafenib — DRUG
    Given PO

Study Details

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) or that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who have progressed on prior chemotherapy. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Regorafenib binds to and inhibits growth factor receptors, which may inhibit the growth of new blood vessels that tumors need to grow. Giving botensilimab, balstilimab, and regorafenib in combination may work better in treating patients with metastatic colorectal cancer than giving these drugs alone.

Key Dates

Start date
May 11, 2023
Status verified
Jan 2026
Primary completion
May 10, 2025
Completion
Aug 25, 2026

Study Design

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

Arms

  • Experimental: Treatment (botensilimab, balstilimab and regorafenib)
    Patients receive botensilimab IV, balstilimab IV, and regorafenib PO on study. Patients also undergo CT and collection of blood throughout the study.

Primary Outcome Measure

Recommended phase 2 dose of botensilimab, balstilimab, and regorafenib (Phase I) [ Time Frame: Cycle 1 (6 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CA

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