Phase 1b2 Study of ADG126 Combined With Pembrolizumab for Treating Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are studying the safety, tolerability, pharmacokinetics, and immune response of ADG126 combined with pembrolizumab in adults with advanced or metastatic solid tumors. This Phase 1b2 open-label study focuses on various solid tumors, especially microsatellite stable colorectal cancer MSS CRC. The study includes dose escalation, expansion, and optimization phases to find the best dosing regimen. Participants receive ADG126, an antibody targeting CTLA-4, and pembrolizumab, a PD-1 blocking antibody, through intravenous infusions every 21 days. Some study groups also receive standard care treatments like trifluridinetipiracil-bevacizumab or fruquintinib. Treatment continues until disease progression, intolerable side effects, withdrawal, or up to 35 cycles. The Phase 2 portion uses randomization to compare two dosing schedules of ADG126 with pembrolizumab. During the study, participants undergo regular assessments including tumor measurements, blood tests, and safety monitoring. Researchers track drug levels, immune responses, disease control, progression-free survival, and overall survival, with follow-up lasting up to two years. Participants may have tumor biopsies and are monitored for adverse events and treatment effects throughout their involvement.

ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors