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

Condition(s) studied

Investigational drug(s) / intervention(s)

MST-0312: A complete treatment cycle is defined as 21 calendar days.

Pembrolizumab: Monoclonal antibody

Study summary

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.

Eligibility

Primary outcome measure(s)

• Incidence of Dose-limiting Toxicities (DLTs) — From baseline to end cycle 1. A complete treatment cycle is defined as 21 calendar days.
• Incidence of Adverse Events, Treatment Emergent Adverse Events, Serious Adverse Events measured by Criteria for Adverse Events Version 6.0 (CTCAE v6.0) — Up to 24 months

Trial sites (6)

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