This phase 1 trial will investigate the safety of an experimental drug, XmAb22841 (XmAb), to treat advanced cancer.
The main outcome will be the safety and tolerability of XmAb. This study is recruiting in Georgia and Texas, USA.
Advanced cancer can be difficult to treat. New drugs are being developed to address this. Immune checkpoint inhibitors (ICIs) are a new class of anti-cancer drugs. They help the immune system to recognize and kill cancer cells. Pembrolizumab (Keytruda) is an ICI licensed to treat some advanced cancers. Pembrolizumab targets a protein called PD-1. XmAb22841 (XmAb) is an experimental drug. It is also an ICI. It targets two proteins – CTLA-4 and LAG-3. XmAb has been effective in animal cancer models. It is unclear what dose of XmAb will be safe to use in patients and if it can be used with pembrolizumab.
This trial will investigate the safety of an experimental drug, XmAb, to treat advanced cancer. The main outcome will be the safety and tolerability of XmAb.
Who are they looking for?
This study will recruit 242 patients with melanoma and other advanced solid tumors. Patients must have an available tumor sample or be willing to have a biopsy.
Patients cannot take part if they have previously not responded to anti-LAG3 therapy. Previous treatment with CTLA4 drugs in the last 4 months is also excluded. Any previous treatment with an ICI is not allowed. Other exclusion criteria are autoimmune diseases, recent antibiotic treatment, organ transplant or remaining side effects from previous therapies.
How will it work
Patients will be randomly assigned to receive either XmAb only or XmAb and pembrolizumab. Multiple doses will be administered. The study will last for 56 days.
The main outcome will be the safety and tolerability of XmAb.