Study of a New Treatment Called ONM-501 Alone and in Combination with Immunotherapy for 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 and when they join the study.
• 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 (an immunotherapy), 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 (an immunotherapy), the expansion phase of the study will be initiated. The expansion phase will enroll people in one to three groups based on tumor indication.

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 human immunodeficiency virus (HIV) if on treatment 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.
• Had major surgery within 4 weeks before the first dose of the study drug.
• Have brain metastases (cancer that had spread to the brain). Some people with brain metastases may be permitted on a case-by-case basis.
• Have an irregular heart rhythm.
• Who are breastfeeding or pregnant.
• Are of childbearing potential that refuse to use a highly effective method of contraception.
• Has uncontrolled or poorly controlled high blood pressure.
• Who has had any major heart issues within 6 months prior to study enrollment.