This trial is being carried out to assess the safety and effectiveness of an experimental drug called BCA101 alone and in combination with pembrolizumab (Keytruda) in advanced solid tumors that are EGFR-positive. The main outcomes to be measured are the occurrence of side effects and response to treatment.
Advanced solid tumors are cancerous growths that have spread and are usually not responsive to standard treatment. BCA101 is an experimental treatment that blocks EGFR (epidermal growth factor receptor) and TGFß (transforming growth factor ß). EGFR is a protein present on the surface of healthy and cancerous cells. If it is damaged it can often result in uncontrolled growth of cancer cells. TGFß is an inflammatory protein. An abnormal TGFß can lead to tumor formation. Experimental studies have shown that BCA101 has activity blocking both abnormal proteins in tumors that are positive for EGFR.
This study will evaluate the safety and effectiveness of BCA101 in advanced EGFR-positive tumors. The main outcomes that will be measured are the occurrence of side effects, tolerability, and response to treatment.
Who are they looking for?
This trial is looking to recruit 292 patients with advanced tumors including uveal melanoma. Patients must have measurable disease and must agree to have tissue samples (biopsies) taken.
Patients will be excluded from this trial if they have received an EGFR treatment within 4-weeks of the first dose of the study drug. Female patients must not be pregnant or breastfeeding. Participants must not have active infections including hepatitis B or C, or HIV and must not have any conditions requiring treatment with steroids.
How will it work
There will be two groups in this study. Group 1 will be treated with BCA101 alone. Group 2 will be treated with BCA101 and pembrolizumab.
Side effects and tolerability to the drugs will be measured over the course of 24-months. Response to treatment and survival without cancer worsening will also be evaluated.