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

Sponsor
Mestag Therapeutics Limited
Study ID
NCT07610941
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cancer-Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MST-0312 — DRUG
    A complete treatment cycle is defined as 21 calendar days.
  • Pembrolizumab — DRUG
    Monoclonal antibody

Study Details

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.

Key Dates

Start date
Apr 9, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
157 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1A
    MST-0312 monotherapy dose escalation
  • Experimental: Module 1B
    MST-0312 monotherapy backfill
  • Experimental: Module 2A
    MST-0312 plus pembrolizumab dose escalation
  • Experimental: Module 2B
    MST-0312 plus pembrolizumab backfill
  • Experimental: Module 2C
    MST-0312 plus pembrolizumab expansion

Primary Outcome Measure

Incidence of Dose-limiting Toxicities (DLTs) [ Time Frame: From baseline to end cycle 1. A complete treatment cycle is defined as 21 calendar days. ]

Central Contacts