A First-in-Human Phase 1b Clinical Study of MST-0312 in Patients with Solid Tumors
Study Identifier:
MST-0312-1001
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
To evaluate M300 in patients with solid tumors.
To evaluate MST-0312 in patients with selected advanced solid tumors
To evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics and anti-tumor activity of MST-0312 alone and in combination with pembrolizumab.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Module 1A
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Drug: MST-0312 monotherapy dose escalation
Drug: Drug: MST-0312
Drug: A complete treatment cycle is defined as 21 calendar days.
Drug: EXPERIMENTAL: Module 1B
Drug: MST-0312 monotherapy backfill
Drug: EXPERIMENTAL: Module 2A
Drug: MST-0312 plus pembrolizumab dose escalation
Drug: Drug: Pembrolizumab
Drug: Monoclonal antibody
Drug: Other Names: Keytruda
Drug: EXPERIMENTAL: Module 2B
Drug: MST-0312 plus pembrolizumab backfill
Drug: EXPERIMENTAL: Module 2C
Drug: MST-0312 plus pembrolizumab expansion
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- Patients with solid tumors.
- * 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.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Emiliano Calvo
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Victor Moreno Garcia
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor