Phase 1AB Study to Test Safety and Tolerability of EBC-129 Alone and with Pembrolizumab in Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of a drug called EBC-129, used alone and with pembrolizumab, in patients with advanced solid tumors. This open-label, phase 1ab study is divided into four parts to identify safe dosing levels and to explore the drugs effects in different patient groups. It aims to find the maximum tolerated dose and recommended phase 2 dose for EBC-129 alone and combined with pembrolizumab, targeting patients who have limited treatment options due to advanced cancer. The study includes four parts Part A tests escalating doses of EBC-129 alone to find safe dosing Part B tests escalating doses of EBC-129 combined with pembrolizumab Part C expands on Part A using the recommended dose of EBC-129 alone in more patients and Part D evaluates dosing schedules in patients with cancer types showing early responses. EBC-129 is given intravenously on Day 1 of each 21-day cycle in Parts A, B, and C, with varying dosing schedules in Part D. Pembrolizumab is administered every 21 days at a fixed dose. Participants will undergo monitoring for adverse events and treatment responses over several cycles, with assessments including tumor response rates and drug concentration measurements. The study tracks serious and treatment-emergent adverse events from before treatment until 30 days after the last dose, with outcome measures extending up to approximately 3.3 years. This includes evaluating tumor control, duration of response, progression, survival rates, and drug levels in the blood to understand the safety and effects of the treatments.

A Study of EBC-129 in Advanced Solid Tumours