NCT07610941 Phase 1 Open Label Trial of MST-0312 Alone and in Combination in Subjects With Solid Malignancies
| NCT ID | NCT07610941 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Mestag Therapeutics Limited |
| Condition | Cancer-Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 157 participants |
| Start Date | 2026-04-09 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 157 participants in total. It began in 2026-04-09 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07610941 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer-Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07610941 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07610941 currently recruiting?
Yes, NCT07610941 is actively recruiting participants. Contact the research team at medical@mestagtx.com for enrollment information.
Where is the NCT07610941 trial being conducted?
This trial is being conducted at Barcelona, Spain, Madrid, Spain, Madrid, Spain, Madrid, Spain and 2 additional locations.
Who is sponsoring the NCT07610941 clinical trial?
NCT07610941 is sponsored by Mestag Therapeutics Limited. The trial plans to enroll 157 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.