509TiPA phase I dose-escalation and expansion trial of intratumorally administered CV8102, alone and in combination with anti-PD-1 in patients with advanced solid tumours

AbstractBackgroundIntratumoral injection of immunomodulating agents is a promising approach to prime antitumor immune responses and to control tumor growth while avoiding major systemic toxicities. Intratumoral CV8102, a TLR7/8/RIG-1 agonist based on noncoding single stranded RNA showed dose dependent single agent activity and synergism with PD-1 blockade in preclinical models.Trial designCV-8102-008 (NCT03291002) is a phase I, open-label, dose escalation and expansion study of intratumoral CV8102 in patients with advanced, inoperable cutaneous melanoma (cMEL), squamous cell carcinoma of the skin (cSCC) or head and neck (hnSCC) or adenoid cystic carcinoma (ACC). Eight intratumoral injections of CV8102 are provided over a 12 weeks period, unless disease progression requiring initiation of next-line therapy or unacceptable toxicity occurs. Patients showing evidence of clinical benefit on single agent CV8102 are eligible for further treatment. Currently the first part of the trial, with escalating doses of single agent CV8102 and CV8102 in combination with anti-PD-1 antibodies to determine the maximum tolerated/ recommended dose (MTD/RCD) guided by a Bayesian logistic regression model with overdose control. and flexible cohort sizes is ongoing. Safety, biological and tumor response according to RECIST 1.1/ir RECIST of CV8102 alone/in combination with anti-PD-1 antibodies will be further characterized in expansion cohorts including anti-PD-1  naïve and refractory patients.Clin...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research