Phase 1 Open Label Trial of MST-0312 Alone and in Combination in Subjects With Solid Malignancies
- 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.
- Acronym
- STARLYS
- Short title
- Phase 1 Open Label Trial of MST-0312 Alone and in Combination in Subjects With Solid Malignancies
- Official title
- A Multi-arm, Open-label, Phase 1 Trial to Evaluate the Safety and Tolerability, Pharmacokinetics and Anti-tumour Activity of MST-0312 When Given Alone and in Combination With Anticancer Treatments in Subjects With Solid Malignancies
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2029-12-31
- First posted
- 2026-05-28
- Registry last updated
- 2026-06-01
- Primary completion date
- 2029-12-31
- Start date
- 2026-04-09
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Mestag Therapeutics Limited
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07610941
- ClinicalTrials.gov ID
- NCT07610941
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Incidence of Dose-limiting Toxicities (DLTs)
Timeframe: 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)
Timeframe: Up to 24 months
Maximum Concentration (Cmax) Derived for MST-0312
Timeframe: 24 months
Time of Maximum Concentration (Tmax)
Timeframe: 24 Months
Area Under the Curve (AUC) for Various Time Intervals
Timeframe: 24 Months
Half Life (t1/2) for MST-0312
Timeframe: 24 Months
Clearance (CL) for MST-0312
Timeframe: 24 Months
Percentage of Participants with Anti-Drug Antibodies (ADAs)
Timeframe: 24 Months
Objective Response Rate (ORR) by RECIST 1.1 and iRECIST
Timeframe: 12 Months
Disease Control Rate (DCR) by RECIST 1.1 and iRECIST
Timeframe: 12 Months
Duration of Response (DoR) by RECIST 1.1 and iRECIST
Timeframe: 12 Months
Progression Free Survival (PFS) by RECIST 1.1 and iRECIST
Timeframe: 12 Months
Best Overall Response (BoR) by RECIST 1.1 and iRECIST
Timeframe: 12 Months
Time To Response (TTR) by RECIST 1.1 and iRECIST
Timeframe: 12 Months
Progression Free Survival 2 (PFS2) by RECIST 1.1 and iRECIST
Timeframe: 48 Months
Overall Survival (OS)
Timeframe: 48 Months
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Male and female subjects of any ethnic origin, aged 18 years and over.
- Must have given written informed consent and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Subject must have a solid malignancy (non-small cell lung cancer (NSCLC), melanoma, bladder cancer, colorectal cancer (CRC) and triple negative breast cancer (TNBC)).
- An ECOG performance status of 0 or 1 with no deterioration over the previous two weeks.
- Willing to permit access to stored historical tumour tissue and prior tumour radiological assessments, cancer treatment history, including response to treatment, and tumour biomarker data, where available.
- Willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other trial procedures.
- Any unresolved toxicity (except alopecia) from prior therapy of ≥2 CTCAE Grade.
- Active or documented history of autoimmune disease requiring interventional therapy.
- Active infection requiring systemic antibiotic, antifungal, or antiviral medication within 14 days prior to first dose of IMP.
- Male or female subjects of childbearing potential unwilling to comply with contraception requirements.
- Hospital Universitari Vall d'HebronBarcelona, SpainNot yet recruiting
- Clinica Universidad De NavarraMadrid, SpainNot yet recruiting
- Hospital Universitario Fundacion Jimenez DiazMadrid, SpainRecruiting
- Hospital Universitario 12 De OctubreMadrid, SpainNot yet recruiting
- Hospital Universitario Hm SanchinarroMadrid, SpainRecruiting
- Hospital Clinico Universitario De ValenciaValencia, SpainNot yet recruiting
- 2025
- 2025-524446-10