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Recruiting NCT07610941

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

Phase I Interventional Cancer-Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MST-0312, Pembrolizumab.
Who it may be relevant to
Registry conditions: Cancer-Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 6 centers
  • 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

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗