Study of a New Treatment Called ONM-501 Alone and in Combination with Cemiplimab in People with Triple Negative Breast Cancer, Advanced Solid Tumors and Lymphomas

About the Study

This is an open-label, non-randomized study.

• All people will receive the study drug ONM-501, injected into their tumor, either alone or in combination with Cemiplimab, a PD-1 checkpoint inhibitor.
• The study will have different groups of participants. People will be assigned to a group based on their tumor testing.
  • The dose escalation groups will establish the ideal dose of ONM-501 alone or in combination with Cemiplimab.
  • The dose expansion groups will include additional patient populations.
  • Everyone will keep taking the medication until their cancer gets worse, the treatment causes severe side effects, or they choose to stop the study. 

What the Study Involves

There are 3 groups to the study:

Group 1

• ONM-501 will be injected directly into the tumor once per week for three weeks, followed by three weeks without ONM-501 administration. Each dosing cycle will be 21 days.

Group 2

• ONM-501 will be injected directly into the tumor once per week for three weeks followed by three weeks without ONM-501 administration. Each dosing cycle will be 21 days. The combination drug, Cemiplimab, will be injected into the vein once every three weeks.

Group 3

• Once the recommended doses are determined for ONM-501 by itself or in combination with Cemiplimab, the expansion phase of the study will be initiated. The expansion phase will enroll people in one to three groups based on tumor indication.

Study Sites

California

Los Angeles

California Research Institute
Lead researcher Ghassan Al-Jazayrly, MD
Contact: Clare Gregorio [email protected]

Florida

Tamarac

BRCR Global
Lead researcher: Chintan Gandhi, MD
Contact: Isabela Vazquez at 541-447-0614 ext 114 or [email protected]

Ohio

Canton

Gabrail Cancer Center Research
Lead reseacher: Nashat Y Gabrail, MD
Contact: Carrie Smith, RN at 330-417-8231 [email protected]

Columbus

Ohio State University
Lead researcher: Joal Beane, MD
Contact: Allison Reynolds, [email protected]

Pennsylvania

Pittsburgh

Allegheny Health Network
Lead researcher: Patrick Wagner, MD
Contact: Shelly Evans, 724-612-2931 or [email protected]

UPMC Hillman Cancer Center
Lead researcher: Liza Villaruz, MD
Contact: Barb Stadterman, 412-647-5554 or  [email protected]

Texas

Dallas

University of Texas Southwestern Medical Center
Lead researcher: Heather McArthur, MD
Contact: 833-722-6237 or [email protected]

Houston

MD Anderson Cancer Center
Lead researcher: Sarina A. Piha-Paul, MD
Contact: Hebah Elbahy, 832-294-7238 or [email protected]

People 18 years and older who meet the following criteria may be able to participate:

• Have triple negative breast cancer, solid tumors or lymphomas that are advanced, cannot be surgically removed, or recurrent and progressing since the last treatment, and for which no other standard therapy exists.
• Have a minimum of one lesion that can be measured and have therapy injected into it.
• Have Hepatitis B or C who have sufficient liver function.
• Have human immunodeficiency virus (HIV) if on established HAART for a minimum of 4 weeks prior to enrollment.
• Have sufficient bone marrow function.
• Have sufficient liver function.

People under the age of 18 and:

• Have another cancer diagnosis active within the previous 2 years.
  • Exceptions: basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy.
• Had major surgery within 4 weeks before the first dose of the study drug.
• Have brain metastases (cancer that had spread to the brain) that have not been treated or are in the posterior fossa, or involve the meninges.
  • Exceptions: stable or previously treated progressing brain metastases (except in the posterior fossa or involving the meninges) may be permitted in a case-by-case basis.
• Have an irregular heart rhythm.
• People who are breastfeeding or pregnant.
• People of childbearing potential that refuse to use a highly effective method of contraception.
• Who has uncontrolled or poorly controlled high blood pressure.
• Who has had any major heart issues within 6 months prior to study enrollment.
• Who has an active infection requiring treatment.
• Is participating in another therapeutic clinical trial.
• Who has known hypersensitivity to any component in the formulation of cemiplimab.
• Who has any active or recent history of a known or suspected autoimmune disease (for example type 1 diabetes, rheumatoid arthritis, psoriasis, or lupus) or recent history of a syndrome that required an anti-inflammatory medication.
• Who has a condition requiring treatment with corticosteroids.