This phase 1/2 trial will investigate the safety of OBT076 in patients with advanced breast cancer.
The main outcomes will be the frequency of side effects and response to treatment. This trial is recruiting at Columbia University Medical Center, NY, US.
Breast cancer (BC) is a highly treatable cancer. The most well-characterized treatments are surgery, chemotherapy (CT) and radiation therapy (RT).Metastatic BC (mBC) is when the cancer cells travel to other parts of the body and form new tumors. New types of drugs are in development for metastatic cancers like mBC. Antibody-drug conjugates (ADCs) are a new type of drug. A drug is attached to an antibody. When administered, the antibody binds to target proteins on the cancer cell. The drug is delivered directly to the cancer cell and kills it. OBT076 is an ADC. It binds to a cell surface protein called CD205.OBT076 is an experimental drug and has not been tested in humans before.
This trial will investigate the safety and effectiveness of OBT076 in patients with mBC. The main outcomes will be the side effects and response to treatment.
Who are they looking for?
This study will 70 recruit patients with HER2-negative mBC. Patients must have tumor cells that are positive for the CD205 protein. Adequate organ and bone marrow function are also necessary for inclusion in the trial.
Patients cannot take part in the trial if they have had CT in the last 3 weeks.RT in the last 4 weeks is also excluded. Patients with brain tumors, kidney dysfunction or other cancer diagnoses in the previous 5 years are excluded from the trial. Other exclusion criteria are heart disease, active infection, autoimmune conditions. Women of childbearing potential are also excluded from the trial.
How will it work
All patients will be treated with OBT076. A range of doses will be administered in this study. The aim is it to identify the maximum tolerated dose (MTD). OBT0876 will be administered once every 3 weeks via intravenous infusion. Once the MTD is established, this will be the maximum dose used in phase 2. Patients will be treated at or below the MTD for up to 1 year in phase 2.
The main outcomes will be the frequency of side effects at 1 year and response to treatment for up to 2 years.