A Phase 2 Study of Botensilimab and Balstilimab Immunotherapy in People with Advanced Colorectal Cancer


Full Title

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


The purpose of this study is to evaluate the safety and effectiveness of botensilimab, alone or combined with balstilimab, in people with metastatic colorectal cancer. Botensilimab and balstilimab may improve the immune system’s ability to fight cancer by taking the brakes off the immune response. They each enable immune cells to detect and destroy cancer cells. Researchers will also compare these two drugs against standard chemotherapy treatments.

Participants in this study will be randomly assigned to receive either botensilimab alone, botensilimab combined with balstilimab, or a standard chemotherapy treatment (regorafenib or trifluridine/tipiracil) for metastatic colorectal cancer. Botensilimab and balstilimab are given intravenously (by vein), and regorafenib and trifluridine/tipiracil are tablets that are taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable metastatic colorectal cancer that has continued to grow despite prior chemotherapy for metastatic disease.
  • Patients may not have previously received immunotherapy, regorafenib, or trifluridine/tipiracil treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.


For more information and to ask about eligibility for this study, please contact the office of Dr. Neil Segal at 646-888-4187.




Phase II (phase 2)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID