drugset / Trial / NCT05405595

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

NCT05405595

Phase 1/2 Recruiting 186 enrolled Adagene Inc Merck Sharp & Dohme LLC · collab
RandomizedSequentialOpen-labelTreatment

Summary

This is a Phase 1b/2, open-label, dose escalation, dose expansion and dose optimization study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors. The study drug ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).

Timeline

Start
2022-06-15
Primary completion
2026-10-31
Completion
2027-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Muzastotug Monoclonal antibody Intravenous
Subject Pembrolizumab Monoclonal antibody
Background Bevacizumab Monoclonal antibody
Background Fruquintinib Small molecule Oral
Background Tipiracil Small molecule
Background Trifluridine Small molecule

Indications

No indication recorded.