This phase 1 study will investigate the dose range and effectiveness of an experimental drug, XmAb23104, in the treatment of advanced breast cancer and other solid tumors.
The main outcome will be the safety and tolerability of XmAb23104. This trial is recruiting in Georgia, Texas, and Virginia, the United States.
Advanced cancers have limited treatment options. New drugs are in development that are more specific than standard chemotherapy. One promising drug type is immune-checkpoint inhibitors (ICIs). Cancer cells (CCs) can go undetected by the immune system by ‘hijacking’ immune checkpoints. ICIs allow the immune system to detect CCs. The immune system can then attack and kill CCs, slowing tumor progression. XmAb23104 (XmAb) is an ICI. It is a bispecific antibody. XmAb blocks two proteins called PD-1 and ICOS. It is unclear what dose of XmAb is safe and effective in humans.
This study will investigate the dose range of an experimental drug, XmAb, in the treatment of advanced cancer. The main outcome will be the safety and tolerability of XmAb.
Who are they looking for?
This trial will recruit 144 patients with advanced triple negative breast cancer and other solid tumors. Patients can take part in the trial if the cancer has progressed despite standard treatment. A tumor biopsy must be performed before starting the trial and after treatment.
Patients cannot take part in the trial if they have recent treatment with other ICIs. This includes recent treatment with nivolumab (Opdivo) or pembrolizumab (Keytruda). Participants cannot have had anti-cancer therapy in the 2 weeks before the trial begins. Other exclusion criteria include immune disorders, diabetes, or uncontrolled medical conditions.
How will it work
All patients will undergo treatment with XmAb. A range of doses will be administered and they will increase during the trial. The study will last 56 days. The authors will assess how the drug acts in the body. They will also measure the effectiveness.
The main outcome will be the safety and tolerability at day 56.