New Treatment in People with Triple Negative Breast Cancer or Advanced Solid Tumors
Clinicaltrials.gov identifier:
NCT06022029
Treatment
Treatment study for people with triple negative breast cancer, advanced solid tumors or lymphomas
Study Contact Information:
Please contact us at (682) 285-1411 or by email at [email protected]
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 , 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 ), 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 ), the expansion phase of the study will be initiated. The expansion phase will enroll people in one to three groups based on tumor indication.
California
City: Los Angeles RECRUITING
Facility: California Research Institute
Contact Info:
[email protected]
Florida
City: Tamarac RECRUITING
Facility: BRCR Global
Contact Info:
[email protected]
541-447-0614
Ohio
City: Canton RECRUITING
Facility: Gabrail Cancer Center Research
Contact Info:
[email protected]
330-417-8231
City: Columbus RECRUITING
Facility: Ohio State University
Contact Info:
[email protected]
Pennsylvania
City: Pittsburg RECRUITING
Facility: Allegheny Health Network
Contact Info:
[email protected]
(724) 612-2931
City: Pittsburgh RECRUITING
Facility: UPMC Hillman Cancer Center
Contact Info:
[email protected]
(412) 647-5554
Texas
City: Dallas RECRUITING
Facility: University of Texas Southwestern Medical Center
Contact Info:
[email protected]
833-722-6237
City: Houston RECRUITING
Facility: MD Anderson Cancer Center
Contact Info:
[email protected]
832-294-7238
Virginia
City: Fairfax RECRUITING
Facility: Virginia Cancer Specialists, PC
Contact Info:
[email protected]
703-636-1473
Other Countries
Country: Australia
State: New South Wales
City: Wollongong RECRUITING
Facility: Cancer Care Wollongong
Contact Info:
[email protected]
+61 2 42439708
Country: Australia
State: Queensland
City: Buderim RECRUITING
Facility: University of the Sunshine Coast Clinical Trials
Contact Info:
[email protected]
+61 421964895
Country: Australia
State: Queensland
City: Southport RECRUITING
Facility: Tasman Oncology Research
Contact Info:
[email protected]
07 5613 2480
Country: Australia
State: South Australia
City: Bedford Park RECRUITING
Facility: Southern Oncology Clinical Research Unit
Contact Info:
[email protected]
People 18 years and older who meet the following criteria may be able to participate:
- Have triple negative breast cancer, 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.