Multi-indication clinical trials help evaluate new medications for future treatments

A multi-indication clinical trial is a way to study the safety and tolerability of a medication or combination of medications in patients with diverse types of cancer or a shared cancer mutation or biomarker. The results from these early phase trials inform the next phase, which may show the clinical benefit of a medication for a specific or varying types of cancer.

This month we are featuring two multi-indication clinical trials offered by Earle A. Chiles Research Institute, a division of Providence Cancer Institute of Oregon. Both trials are open to patients with solid tumor or blood cancers, and both studies will evaluate investigational medications given alone and in combination with other medications.

Additionally, both trials include sarcoma groups (angiosarcoma and chondrosarcoma, respectively). We make the distinction in part because July is Sarcoma Cancer Awareness Month. Although it is rare, there are over 50 types of sarcomas and each one is distinctive in the way it affects the body, how fast it grows and how it responds to treatment.

Providence Cancer Institute is in the unique position to fill a gap in sarcoma research. In May, Jianguo Huang, Ph.D., joined us to lead the Preclinical Cancer Therapy Laboratory where he will focus on developing therapeutic strategies for treating soft tissue sarcomas.

Early phase study of AGEN1181 open for patients with advanced solid tumor cancers

This phase I, multicenter clinical trial is currently recruiting patients with cancer that is a locally advanced solid tumor or has spread to new parts of the body and for which no standard therapy is available or standard therapy has failed. Cancer types considered for this trial include but are not limited to:

  • Angiosarcoma
  • Colorectal cancer without liver metastases
  • Endometrial cancer
  • Fibrolamellar carcinoma
  • Melanoma
  • Non-small cell lung cancer
  • Ovarian cancer

Why is this trial relevant?

The purpose of the trial is to study the safety and tolerability of the investigational medication AGEN1181 (botensilimab) alone and in combination with balstilimab for future studies. AGEN1181 is a next-generation cytotoxic T-lymphocyte associated protein-4 (CTLA-4) inhibitor that targets cells that are a part of the body’s immune system.

Balstilimab is designed to block a protein called programmed-death 1 (PD-1) and prevent their communication with receptors on the tumor cells that can affect the body’s ability to identify and fight cancer. By blocking PD-1, the immune system has a better chance at fighting cancer. Balstilimab is also being studied in two other trials for patients with advanced cancers.

The trial will also evaluate how the body breaks down AGEN1181 and its effect on the body. In addition, researchers will evaluate the effectiveness of the medications and whether the body produces antibodies against them.

Finally, this clinical trial will also provide an opportunity for researchers to study certain proteins called biomarkers that give more information about the disease and the body’s response to the disease.

What researchers learn from this study will help inform the next phase, which involves testing how effective the medications are in treating solid tumor cancers.

Providence Cancer Institute is the only site in the Pacific Northwest offering the trial. Rachel E. Sanborn, M.D., medical director, Providence Thoracic Oncology Program; medical director, Phase I Clinical Trials Program, is the lead investigator.

Learn more about this trial here: Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

Phase I study of IGM-8444 alone and in combination with other medications is open

This is a phase I trial to evaluate the safety and tolerability of the investigational medication IGM-8444 at different doses and schedules. IGM-8444 will be given alone and in combination with birinapant, Venetoclax or the chemotherapy regimen, FOLFIRI, in patients with solid tumor and blood cancer that have not improved with treatment, has gotten worse or has spread. Researchers also will evaluate how the body processes IGM-8444.

IGM-8444 is an engineered antibody that targets and binds to death receptor 5 (DR5), a protein on the surface of certain cells that may kill cancer cells when activated. DR5 is found at higher levels on tumor cells than on normal human cells. Targeting DR5 may help facilitate cell death and eliminate cancer cells.

Patients with the following types of solid tumor and blood cancers will be considered for this trial:

  • Colorectal cancer
  • Gastric cancer
  • Non-small cell lung cancer
  • Chondrosarcoma  
  • Non-Hodgkin’s lymphoma
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)

Escalation and expansion stages

Patients will be enrolled in two stages: a dose-escalation stage and an expansion stage. An escalation stage aims to establish the maximum tolerated dose of the medication; and a dose expansion stage incorporates additional patients with different trial eligibility criteria, such as cancer types.

The escalation stage of this trial will investigate IGM-8444 in patients with solid tumors; IGM-8444 in combination with FOLFIRI for colorectal cancer patients; IGM-8444 in combination with birinapant in patients with solid tumors; and IGM-8444 in combination with Venetoclax in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

The IGM-8444 (only) expansion group will enroll solid tumor patients and may include non-Hodgkin’s lymphoma patients. The IGM-8444 FOLFIRI expansion group (with or without bevacizumab) will enroll colorectal cancer patients. The IGM-8444 and birinapant combination expansion group will enroll solid tumor patients; and the IGM-8444 in combination with Venetoclax group will enroll patients with CLL/SLL.

Providence Cancer Institute is the only site in Oregon offering the trial. Hagen Kennecke, M.D., MHA, FRCPC, medical oncologist and medical director of gastrointestinal oncology at Providence Cancer Institute, is the lead investigator.

Learn more about the trial sponsored by IGM Biosciences here:

Phase I Study of IGM-8444 as a Single Agent and in Combination in Subjects with Relapsed and/or Refractory Solid Cancers

Contact us to find out more

For more information about these studies or to refer a patient, please contact our Clinical Research office:  

New research studies are added on a regular basis. To view more clinical studies, visit our website:

    Studies for many types of cancer and advanced cancers

    All cancer studies at Providence Cancer Institute of Oregon

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Novel immunotherapy for pancreatic cancer employed by Providence researchers featured in New England Journal of Medicine

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