KEY TAKEAWAYS
- The early phase I trial aimed to assess the efficacy, safety, and anti-tumor activity of ON-01910 in RDEB advanced/metastatic cSCCs pts.
- Secondary objectives include assessing the impact on QoL and to perform biomarker analysis on patient tissue. The trial is ongoing.
Recessive Dystrophic Epidermolysis Bullosa(RDEB) is a rare blistering disease caused by collagen seven(COL7A1) mutations. This leads to aggressive cutaneous squamous cell carcinomas(cSCCs) with a high mortality risk, and current treatments, like immune checkpoint inhibitors and chemotherapy, have limited success. More effective therapies are urgently needed for advanced RDEB-associated cSCCs.
Researchers aimed to assess the efficacy, safety, and anti-tumor activity of rigosertib(ON-01910), a PLK-1 inhibitor in RDEB advanced/metastatic cSCCs pts.
The study previously showed that RDEB SCC cancer cells are especially sensitive to a drug called polo-like kinase-1(PLK-1) siRNA. They tested 8 PLK-1 inhibitors to see which was most effective at killing cancer cells.
This ongoing study investigates ON-01910’s effectiveness against tumors and its safety. They also analyze its impact on patients’ quality of life(QoL) and examine biomarkers in their tissue. The study started in August 2021 and has one patient enrolled in the oral arm at Thomas Jefferson University in the USA. Safety is assessed using CTCAE v5, and tumor response is evaluated in lymph nodes (RECIST 1.1) and skin through clinical examination and tumor measurements. The key eligibility criteria for patients(pts) must have RDEB diagnosis, advanced cSCC confirmed histologically, failed standard treatments, and not receive other cancer therapies concurrently.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.TPS9604
Clinical Trial: https://www.clinicaltrials.gov/study/NCT04177498
Lauren Banner, Linda Hosler, Matthew Parris, Mark Stephen Gelder, Martin Laimer, Johann Bauer, Andrew South, and Neda Nikbakht. DOI: 10.1200/JCO.2023.41.16_suppl.TPS9604 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) TPS9604-TPS9604.
