> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-1-open-label-trial-of-mst-0312-alone-and-in-cc494be5-eb98-413e-b43d-940b4c12b048 > Record changed: 2026-10-13 # Phase 1 Open Label Trial of MST-0312 Alone and in Combination in Subjects With Solid Malignancies NCT07610941 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) Participants 157 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) Lead sponsor Mestag Therapeutics Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) Start date 2026-04-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) Number of sites 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Acronym** STARLYS Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Short title** Phase 1 Open Label Trial of MST-0312 Alone and in Combination in Subjects With Solid Malignancies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) ## Dates **Completion date** 2029-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **First posted** 2026-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Registry last updated** 2026-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Primary completion date** 2029-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Start date** 2026-04-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) ## Size and sites **Participants** 157 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Planned participants** 157 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Number of sites** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Lead sponsor** Mestag Therapeutics Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) ## Identifiers **Registry ID** NCT07610941 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **ClinicalTrials.gov ID** NCT07610941 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) ## Outcomes ### Primary outcomes 1. Incidence of Dose-limiting Toxicities (DLTs) Timeframe: From baseline to end cycle 1\. A complete treatment cycle is defined as 21 calendar days. 2. 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 ### Secondary outcomes 1. Maximum Concentration (Cmax) Derived for MST-0312 Timeframe: 24 months 2. Time of Maximum Concentration (Tmax) Timeframe: 24 Months 3. Area Under the Curve (AUC) for Various Time Intervals Timeframe: 24 Months 4. Half Life (t1/2) for MST-0312 Timeframe: 24 Months 5. Clearance (CL) for MST-0312 Timeframe: 24 Months 6. Percentage of Participants with Anti-Drug Antibodies (ADAs) Timeframe: 24 Months 7. Objective Response Rate (ORR) by RECIST 1.1 and iRECIST Timeframe: 12 Months 8. Disease Control Rate (DCR) by RECIST 1.1 and iRECIST Timeframe: 12 Months 9. Duration of Response (DoR) by RECIST 1.1 and iRECIST Timeframe: 12 Months 10. Progression Free Survival (PFS) by RECIST 1.1 and iRECIST Timeframe: 12 Months 11. Best Overall Response (BoR) by RECIST 1.1 and iRECIST Timeframe: 12 Months 12. Time To Response (TTR) by RECIST 1.1 and iRECIST Timeframe: 12 Months 13. Progression Free Survival 2 (PFS2) by RECIST 1.1 and iRECIST Timeframe: 48 Months 14. Overall Survival (OS) Timeframe: 48 Months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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. ### Exclusion criteria - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) ## Sites - 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 Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) ## References ### Other registry identifiers (2) - 2025 - 2025-524446-10 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07610941) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Mestag Therapeutics Limited](https://trialight.com/data/company/mestag-therapeutics-limited-9e4fc0a3-0664-42fd-9660-f26d43b7ac64.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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