Phase 1 Open Label Trial of MST-0312 Alone and in Combination in Subjects With Solid Malignancies

The STARLYS trial is an adaptive, modular, Phase 1, open-label, multi-part, clinical trial evaluating MST-0312 in selected solid tumors. MST-0312 is a targeted bispecific antibody that is designed to locally stimulate the lymphotoxin beta receptor (LTBR) in order to boost the body's immune response to cancer. The LTBR pathway is important in forming tertiary lymphoid structures and high endothelial venules in tumors, which have been associated with improved patient outcomes. The purpose of this study is to determine the safety and tolerability, pharmacodynamics, pharmacokinetics and anti-tumor activity of MST-0312 in subjects with solid malignancies (initially non-small cell lung cancer (NSCLC), melanoma, bladder cancer, colorectal cancer (CRC) and triple negative breast cancer (TNBC)) when administered either as monotherapy or in combination with anti-cancer treatments (initially pembrolizumab). The STARLYS trial is the first time MST-0312 has been administered to humans.

NCT Number	NCT07610941
Lead Sponsor	Mestag Therapeutics Limited
Conditions	Cancer-Neoplasms
Enrollment	157 participants
Start Date	2026-04-09
Primary Completion	2029-12-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-01