Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours

NCT04855435 | Recruiting Phase 1

• 1 other identifier: MBS8-101
• Study Type: interventional
• Target: 106
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Advanced Solid Tumor; Uveal Melanoma, Metastatic; Cutaneous Melanoma

Outcome Measures

Primary Outcomes (3)

• Adverse events

  Type and number of adverse events

  42 days

• Dose limiting toxicities

  Dose limiting toxicities (DLTs) and the MTD for determination of RP2D of MBS8(1V270). Stage I only

  23 days

• Safety related biomarkers

  Plasma levels of safety related cytokines IL-6 and TNF-alpha wil be assessed

  23 days

Secondary Outcomes (2)

• Best overall response

  42 days

• Pharmacokinetic profile of drug substance

  22 days

Study Arms (2)

MBS8(1V270)

EXPERIMENTAL

Monotherapy arm

Drug: MBS8(1V270)

MBS8 (1V270) + pembrolizumab

EXPERIMENTAL

MBS8 (1V270) + pembrolizumab combination arm

Drug: MBS8(1V270); Drug: MBS8(1V270) and pembrolizumab combination

Interventions

MBS8(1V270) DRUG

MBS8(1V270) monotherapy

MBS8 (1V270) + pembrolizumab; MBS8(1V270)

MBS8(1V270) and pembrolizumab combination DRUG

MBS8(1V270) and pembrolizumab combination

MBS8 (1V270) + pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥18 years.
• Diagnosis of a histologically or cytologically confirmed solid tumour that was advanced and with progression. No standard treatment existed, or the participant refused standard treatment. Experimental immunotherapy appeared as a feasible exploratory treatment option as per Investigator's assessment.
• Tumour lesion(s) accessible to serial biopsies.
• Was willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and tumour biopsies. Mandatory Baseline and on-treatment tumour biopsies were required. However, a biopsy may have been omitted if the procedure was deemed medically unsafe or not feasible, based on the Investigator's clinical judgment and after discussion with the Medical Monitor (or Sponsor's designee).
• Measurable disease according to RECIST v1.1. Previously irradiated lesions were measurable if subsequent progression was documented.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
• Life expectancy \>3 months as assessed by the Investigator.
• Adequate bone marrow, cardiopulmonary, renal and hepatic functions:
• Haemoglobin ≥5.6 mmol/L (≥90 g/dL) (without transfusion or erythropoietin therapy within 4 weeks prior to therapy)
• Neutrophils ≥1.5×109/L, without growth factor stimulation within 3 weeks prior to the blood test
• Platelet count ≥75×109/L
• Serum creatinine ≤1.25×ULN or creatinine clearance ≥50 mL/min (by CKD-EPI formula)
• Hepatic function: AST and ALT ≤2.5×ULN; (5×ULN in the case of liver metastases); bilirubin ≤1.5×ULN except in the case of Gilbert's syndrome and 2×ULN in the case of liver metastases.
• All participants of childbearing potential (defined as \<2 years after last menstruation or not surgically sterile) must have had a negative highly sensitive pregnancy test at Screening (urine/serum) and agreed to use highly effective method for contraception according to the European Union (EU) Clinical Trial Facilitation Group guidance from time of signing the informed consent form (ICF) until at least 120 days after the last administration of trial drug. The partners of participants with childbearing potential must have also applied contraceptive methods and were recommended not to donate sperm.
• Ability to understand and sign the ICF.

You may not qualify if:

• Have had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy within 4 weeks prior to Screening (6 weeks required for nitrosourea or mitomycin) except for medications with half-lives \<5.5 days.
• Metastatic disease that involved major airways or blood vessels or centrally located mediastinal tumour masses of large volume with close relation to the major airways, where tumour necrosis may have caused perforation or severe bleeding episodes. Primary or metastatic intestinal disease in situ where tumour necrosis may have caused gastrointestinal perforation.
• Use of investigational agent in the 4 weeks or 5 half-lives prior to the first dose of MBS8(1V270), whichever was shortest.
• Major surgical procedure within 14 days prior to the first dose of trial treatment.
• Had a history of another primary malignancy, except for:
• Malignancy treated with curative intent and with no known active disease within 2 years prior to the first dose of MBS8(1V270)
• Adequately treated non-invasive basal skin cancer or squamous cell skin carcinoma
• Adequately treated uterine cervical cancer Stage 1B or less.
• Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids \[\>10 mg prednisone per day or equivalent, except topical or inhaled\] cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-IL-6 receptor agents, and anti-tumour necrosis factor \[TNF\]α agents) within 2 weeks prior to initiation of trial treatment, or anticipation of need for systemic immunosuppressive medication during trial treatment.
• Treatment with androgen deprivation therapies such as luteinizing hormone-releasing hormone (LHRH) (gonadotropin-releasing hormone \[GnRH\]) agonists within 2 weeks prior to initiation of trial treatment.
• Ongoing irAEs and/or AEs Grade ≥2 not resolved from previous therapies except vitiligo, resolved atopy, limited psoriasis, stable neuropathy Grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy.
• Had uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, human immunodeficiency virus (HIV), immune dysfunction such as autoimmune disease, psychiatric illness such as depression or suicidal tendency or social situations that would have limited compliance with trial requirements.
• Had active or history of immunologic-mediated disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, or Guillain-Barré syndrome.
• Had clinically significant cardiac disease, including:
• Known congestive heart failure Grade III or IV by the New York Heart Failure Association (see Appendix A)

Sponsors & Collaborators

• MonTa Biosciences ApS: lead

Study Sites (5)

Herlev and Gentofte Hospital, Center for Cancer Research

Herlev, DK-2730, Denmark

RECRUITING

Institut Catalá de Oncologia - Hospital Duran i Reynals.

Barcelona, Spain

NOT YET RECRUITING

Fundacion Instituto de Investigacion Sanitaria Fundacion Jimenez Diaz (FJD)

Madrid, 28015, Spain

RECRUITING

Centro Integral Oncológico Clara Campal (CIOCC)

Madrid, 28050, Spain

RECRUITING

Consorcio Hospital General Universitario de Valencia

Valencia, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Uveal Melanoma; Neoplasm Metastasis; Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kristoffer S Rohrberg, MD PhD

  University Hospital of Denmark, Department of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon S Jensen, PhD

CONTACT

+45 5118 6306; simonjensen@montabiosciences.com

Steven Glazer, MD

CONTACT

+45 25674434; stevenglazer@montabiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open-label, single arm, multinational, multicenter Phase I trial

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 22, 2021
• Study Start: April 12, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2025-05

Locations

DK (1); ES (4)