Phase III Study of NUC-7738 Alone and with Pembrolizumab in Adults with Advanced Solid Tumors, Melanoma, and Lymphoma

What this Trial Is About

Researchers are investigating NUC-7738, a nucleotide analogue, in patients with advanced solid tumours and lymphoma through a Phase III dose-escalation and expansion study. The study aims to assess the safety, tolerability, and appropriate dosing schedule of NUC-7738 given alone or combined with pembrolizumab. The trial includes patients with various advanced cancers, including cutaneous melanoma and lymphoma, to explore treatment effects and clinical activity of these therapies. Participants receive NUC-7738 intravenously on either a weekly or fortnightly schedule. In combination cohorts, pembrolizumab is administered intravenously every three weeks alongside NUC-7738. Phase I focuses on dose escalation and safety across two dosing schedules, while Phase II involves dose confirmation and expansion in additional patients, including specific cohorts for melanoma and lymphoma. Biopsies are required for most patients to monitor tumour response. During the study, participants undergo regular assessments including tumour size evaluation every 8 weeks, laboratory tests, physical exams, vital signs monitoring, and electrocardiograms up to 22 months. Researchers will track adverse events, dose-limiting toxicities, pharmacokinetics, and clinical responses such as objective response rate and disease control rate. The study continues safety monitoring until 30 days after the last dose, with detailed pharmacokinetic sampling during early cycles.

A Safety, Pharmacokinetic and Clinical Activity Study of NUC-7738 in Patients With Advanced Solid Tumours and Lymphoma