MedTrace Logo

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

NCT07610941 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2026-06-01

No results posted yet for this 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.

Conditions

  • Cancer-Neoplasms

Interventions

DRUG

MST-0312

A complete treatment cycle is defined as 21 calendar days.

DRUG

Pembrolizumab

Monoclonal antibody

Sponsors & Collaborators

  • Mestag Therapeutics Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-09
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07610941 on ClinicalTrials.gov