Abstract 597TiP
Background
TRPV6 is the 6th member of the transient receptor potential cation channel (vanilloid family) and is predominantly distributed to the apical membranes of Ca2+ transporting epithelial cells. TRPV6 is overexpressed in cancers of epithelial origin. SOR-C13 is a 13-mer synthetic peptide of the C-terminus of soricidin, which is a specific inhibitor of TRPV6. It has been well-tolerated in patients with advanced solid tumours of epithelial origin and showed promising antitumor activities. This phase Ib study explores this agent's safety and efficacy in patients with advanced solid tumours, including ovarian, pancreatic, and prostate cancers.
Trial design
This is a dose-escalation, investigator-initiated, industry-supported phase Ib clinical trial. Patients receive 2 doses per week per cycle of 28 days in a 3 + 3 design over 4 cohorts. To better detect safety and efficacy signals, a dose expansion cohort of 12 patients at the MTD or at the highest protocol dose (30 mg/kg) is also planned. Intrapatient dose escalation is permitted. The final RP2D will be decided at the best judgment of the investigators based on dose-limiting toxicities (DLTs), safety profile, patient tolerance, biological activities, and clinical efficacy signals. Imaging-based therapy response will include computed tomography (using RECIST 1.1) and Radiomics/volumetric assessment. Biomarker analysis will be performed on biopsies and blood draws. Objectives: Primary objectives: To define the maximum tolerated dose (MTD) To define the safety profiles of the treatment Secondary objectives: To evaluate clinical response signals to the treatment. To assess predictive biomarkers (baseline molecular mutation status) and/or resistant pathways by comparing molecular signatures at baseline versus at the time of relapse in patients who have achieved objective responses.
Clinical trial identification
NCT03784677.
Editorial acknowledgement
Legal entity responsible for the study
Siqing Fu, MD, PhD.
Funding
NCI.
Disclosure
S. Fu: Research grant/Funding (self): Soricimed Biopharma Inc.. F. Shaikh: Full/Part-time employment: Image Analysis Group. D. Dupont-Roettger: Full/Part-time employment: Image Analysis Group. S. Bisdas: Full/Part-time employment: Image Analysis Group. D. Dugourd: Full/Part-time employment: Soricimed Biopharma. All other authors have declared no conflicts of interest.