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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Incidence of Dose-limiting Toxicities (DLTs) [Срок оценки: 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) [Срок оценки: Up to 24 months]

Вторичные конечные точки (12)

• Maximum Concentration (Cmax) Derived for MST-0312 [Срок оценки: 24 months]
• Time of Maximum Concentration (Tmax) [Срок оценки: 24 Months]
• Area Under the Curve (AUC) for Various Time Intervals [Срок оценки: 24 Months]
• Half Life (t1/2) for MST-0312 [Срок оценки: 24 Months]
• Clearance (CL) for MST-0312 [Срок оценки: 24 Months]
• Percentage of Participants with Anti-Drug Antibodies (ADAs) [Срок оценки: 24 Months]
• Objective Response Rate (ORR) by RECIST 1.1 and iRECIST [Срок оценки: 12 Months]
• Disease Control Rate (DCR) by RECIST 1.1 and iRECIST [Срок оценки: 12 Months]
• Duration of Response (DoR) by RECIST 1.1 and iRECIST [Срок оценки: 12 Months]
• Progression Free Survival (PFS) by RECIST 1.1 and iRECIST [Срок оценки: 12 Months]
• Best Overall Response (BoR) by RECIST 1.1 and iRECIST [Срок оценки: 12 Months]
• Time To Response (TTR) by RECIST 1.1 and iRECIST [Срок оценки: 12 Months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 6 центров

• Hospital Universitari Vall d'Hebron — Barcelona
• Clinica Universidad De Navarra — Madrid
• Hospital Universitario Fundacion Jimenez Diaz — Madrid
• Hospital Universitario 12 De Octubre — Madrid
• Hospital Universitario Hm Sanchinarro — Madrid
• Hospital Clinico Universitario De Valencia — Valencia

Идентификаторы

NCT: NCT07610941 · MST-0312-1001 · 2025-524446-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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