๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-09-02

A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer (NCT05608044)

A Randomized, Open-Label, Phase 2 Study of Botensilimab (AGEN1181) as Monotherapy and in Combination With Balstilimab (AGEN2034) or Investigator's Choice Standard of Care (Regorafenib or Trifluridine and Tipiracil) for the Treatment of Refractory Metastatic Colorectal Cancer

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Agenus Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: HonorHealth Research Institute โ€” Scottsdale, Arizona

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (65 Sites)

Showing the first 25 of 65 sites.

  • HonorHealth Research Institute โ€” Scottsdale, Arizona
  • City of Hope National Medical Center โ€” Duarte, California
  • Keck School of Medicine of the University of Southern California โ€” Los Angeles, California
  • Rocky Mountain Cancer Center - Aurora โ€” Aurora, Colorado
  • University of Colorado โ€” Denver, Colorado
  • Medical Oncology Hematology Consultants โ€” Newark, Delaware
  • Florida Cancer Specialists and Research Institute - Lake Mary โ€” Lake Mary, Florida
  • Beth Israel Deaconess Medical Center โ€” Boston, Massachusetts
  • Dana-Farber Cancer Institute โ€” Boston, Massachusetts
  • University of Michigan โ€” Ann Arbor, Michigan
  • Atlantic Health System - Morristown Medical Center โ€” Morristown, New Jersey
  • Weill Cornell Medicine โ€” New York, New York
  • Mount Sinai Hospital - New York โ€” New York, New York
  • Memorial Sloan Kettering โ€” New York, New York
  • Cleveland Clinic โ€” Cleveland, Ohio
  • Earle A. Chiles Research Institute - Robert W. Franz Cancer Center - Providence Cancer Institute โ€” Portland, Oregon
  • Oregon Health & Science University (OHSU) โ€” Portland, Oregon
  • Lifespan Clinical Research Center/Cancer Institute (Providence Rhode Island) โ€” East Providence, Rhode Island
  • Tennessee Oncology Nashville (Sarah Cannon) โ€” Nashville, Tennessee
  • Vanderbilt University School of Medicine โ€” Nashville, Tennessee
  • Texas Oncology - Austin Midtown โ€” Austin, Texas
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center โ€” Dallas, Texas
  • MDACC โ€” Houston, Texas
  • Virginia Cancer Specialists/NEXT Virginia โ€” Fairfax, Virginia
  • Swedish Cancer Institute โ€” Seattle, Washington

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—