Agenus Research Trials

Agenus and our partners are studying Botensilimab in 10 research trials at 51 universities and hospitals.

Northwestern University in Evanston, Illinois is one of several locations conducting Botenselimab trials.

Current Botensilimab Trials

For information on Agenus’ currently enrolling trials, click here

A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma

This study is an open-label, 2-part, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab in participants with advanced cutaneous melanoma refractory to checkpoint inhibitor therapy.

FOLFOX and Bevacizumab in Combination with Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer

This phase I/II trial tests the safety, side effects, best dose, and efficacy of combination therapy with FOLFOX, bevacizumab, botensilimab and balstilimab (3B-FOLFOX) in treating patients with microsatellite stable (MSS) colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, is designed to help the body’s immune system attack the cancer, and may also interfere with the ability of tumor cells to grow and spread. The combination of these drugs may lead to improved disease control and outcomes in patients with MSS metastatic colorectal cancer.

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

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 (blocks) certain 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.

Doxorubicin, Zalifrelimab, Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma

This phase II trial studies how well doxorubicin together with zalifrelimab, botensilimab and balstilimab work in treating patients with soft tissue sarcoma that has spread to other places in the body (advanced or metastatic). Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as zalifrelimab, 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. Giving doxorubicin, zalifrelimab, botensilimab and balstilimab may work better in treating patients with soft tissue sarcoma compared to doxorubicin alone.

Botensilimab, Balstilimab, and Liposomal Doxorubicin in Combination with Ultrasound-Mediated Blood Brain Barrier Opening for the Treatment of Patients with Newly Diagnosed Glioblastoma

This phase II trial tests how well botensilimab, balstilimab, and liposomal doxorubicin work in combination with ultrasound-mediated blood brain barrier opening, using the SonoCloud-9 device, for the treatment of patients with newly diagnosed glioblastoma. The SonoCloud-9 device is surgically placed in the skull and works by temporarily increasing the permeability of the blood brain barrier, using ultrasound and a medication called Definity, to allow increased uptake of the treatment medications to the tumor cells. Botensilimab and balstilimab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell’s DNA and may kill cancer cells. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. It also may enhance the reaction to the immunotherapy medications. Giving botensilimab, balstilimab and liposomal doxorubicin in combination with ultrasound mediated blood brain barrier opening may kill more tumor cells in patients with newly diagnosed glioblastoma.

Botensilimab and Balstilimab versus Nivolumab and Ipilimumab for the Treatment Advanced Clear Cell Renal Cell Carcinoma, ARCITECT Trial

This phase II trial tests how well botensilimab and balstilimab versus nivolumab and ipilimumab works to treat patients with clear cell renal cell carcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as botensilimab, balstilimab, nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. They work by binding to a substance in the body, including tumor cells, to help the body’s immune system kill the tumor cells. Combination nivolumab and ipilimumab is the standard frontline treatment for patients with advanced clear cell carcinoma; however, even with good initial response, most patients still progress on this therapy. Giving botensilimab and balstilimab may be more safe and effective than standard treatment for patients with advanced clear cell renal cell carcinoma.

Anti-CD137 and an Anti-CTLA-4 Monoclonal Antibody in Patients with Advanced Cancer

This study is an open-label, Phase 1, multicenter study to evaluate the safety, and tolerability of AGEN2373 as a monotherapy and in combination with botensilimab—and to assess the maximum tolerated dose in patients with advanced solid tumors.

Study of AGEN1571 in Participants With Advanced Solid Tumors

This is an open-label, Phase 1, two-part trial to determine recommended doses and evaluate the safety and tolerability of AGEN1571 both as a monotherapy and in combination with balstilimab and/or botensilimab in participants diagnosed with advanced solid tumors.

Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

This study is an open-label, Phase 1 study to evaluate the safety and tolerability of botensilimab as a monotherapy and in combination with balstilimab—and to assess the maximum tolerated dose in participants with advanced solid tumors.

A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer

The goal of this clinical trial is to test if the addition of botensilimab to standard chemotherapy improves the efficacy compared to just chemotherapy alone in participants with metastatic pancreatic cancer. One group of participants will only receive chemotherapy while a second group of participants will receive botensilimab and chemotherapy.