Actively Recruiting
Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours
Led by MonTa Biosciences ApS · Updated on 2026-05-12
106
Participants Needed
5
Research Sites
320 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Phase I trial is evaluating safety, tolerability, pharmacokinetics and preliminary efficacy of MBS8(1V270) in subjects with advanced solid tumours. The trial is designed to provide data for further clinical development of MBS8(1V270)
CONDITIONS
Official Title
Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Histologically or cytologically confirmed advanced solid tumor with progression and no standard treatment available or refused standard treatment
- Tumor lesions accessible for serial biopsies
- Willing and able to comply with scheduled visits, treatment, lab tests, and tumor biopsies
- Measurable disease according to RECIST v1.1, including previously irradiated lesions if progression documented
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy greater than 3 months (Stage I) or greater than 3 months (Stage II)
- Adequate bone marrow, cardiopulmonary, renal, and hepatic function based on specified lab values
- Negative pregnancy test and agreement to use effective contraception if of childbearing potential
- Ability to understand and sign informed consent
- Prior systemic anti-cancer therapy or investigational agents with appropriate washout and recovery periods
- No systemic steroids greater than 10 mg/day prednisone-equivalent within 14 days before treatment
- Specific inclusion criteria for Stage II cohorts regarding melanoma diagnosis, prior treatments, and disease status
You will not qualify if you...
- Biologic, hormonal, chemotherapy, or radiation therapy within 4 weeks prior to screening (6 weeks for certain drugs)
- Metastatic disease involving major airways, blood vessels, or risk of tumor necrosis leading to perforation or bleeding
- Use of investigational agents within 4 weeks or 5 half-lives before first dose
- Major surgery within 14 days before first dose
- History of other primary malignancies except certain treated cancers
- Treatment with systemic immunosuppressive medication within 2 weeks prior to trial
- Treatment with androgen deprivation therapies within 2 weeks prior to trial
- Ongoing immune-related adverse events grade 2 or higher not resolved from previous therapies
- Uncontrolled intercurrent or chronic illness including active infections and immune dysfunctions
- History or active immunologic-mediated diseases
- Clinically significant cardiac disease or severe allergic episodes
- Hypersensitivity to MBS8(1V270) components
- History of seizure disorders uncontrolled on medication
- Clinically significant coagulation or bleeding disorders
- Women or men of reproductive potential not using effective contraception
- Pregnant or lactating women
- Any condition or therapy that may confound trial results or jeopardize participation
- Autoimmune disorders requiring immune-modulating treatment in the last 2 years
- Additional exclusions for Stage II cohorts including prior severe immune-related toxicity, interstitial lung disease, concurrent anti-cancer therapy, and brain metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Herlev and Gentofte Hospital, Center for Cancer Research
Herlev, Denmark, DK-2730
Actively Recruiting
2
Institut Catalá de Oncologia - Hospital Duran i Reynals.
Barcelona, Spain
Not Yet Recruiting
3
Fundacion Instituto de Investigacion Sanitaria Fundacion Jimenez Diaz (FJD)
Madrid, Spain, 28015
Actively Recruiting
4
Centro Integral Oncológico Clara Campal (CIOCC)
Madrid, Spain, 28050
Actively Recruiting
5
Consorcio Hospital General Universitario de Valencia
Valencia, Spain
Actively Recruiting
Research Team
S
Simon S Jensen, PhD
CONTACT
S
Steven Glazer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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