Phase
Condition
Neoplasms
Treatment
MBS8(1V270)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female aged ≥ 18 years
Diagnosis of histologically- or cytologically-confirmed solid tumour that isadvanced and with progression. No standard treatment exists, or the subject refusesstandard treatment. Experimental immunotherapy appears as feasible exploratorytreatment option as per investigator assessment.
Tumour lesion(s) accessible to serial biopsies.
Must be willing and able to comply with scheduled visits, treatment schedule,laboratory tests, tumour biopsies.
Measurable disease according to RECIST V1.1. Previously irradiated lesions aremeasurable if subsequent progression is documented.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
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 erythropoietintherapy within 4 weeks prior to therapy);
Neutrophils ≥1.5 x 109/L, without growth factor stimulation within 3 weeksprior to the blood test;
Platelet count ≥ 75 × 109/L;
Serum creatinine ≤ 1.25 times ULN or creatinine clearance ≥50 mL mL/min (byCKD-EPI formula);
Hepatic function: AST and ALT ≤ 2.5 x ULN; (5 × ULN in the case of livermetastases); bilirubin ≤ 1.5 × ULN except in case of Gilbert's disease and 2 ×ULN in case of liver metastases.
All subjects of childbearing potential (defined as < 2 years after last menstruationor not surgically sterile) must have a negative highly sensitive pregnancy test atscreening (urine/serum) and agree to use highly effective method for contraceptionaccording to the European Union (EU) Clinical Trial Facilitation Group guidance fromtime of signing the informed consent form (ICF) until at least 120 days after thelast administration of trial drug. The partners of subjects with childbearingpotential must also apply contraceptive methods and are recommended not to donatesperm.
Ability to understand and sign the ICF.
Exclusion
Exclusion Criteria:
Has had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapywithin 4 weeks prior to screening (6 weeks required for nitrosourea or mitomycin)except for medications with half-lives <5.5 days.
Metastatic disease that involves major airways or blood vessels, or centrallylocated mediastinal tumour masses of large volume with close relation to the mayorairways where tumour necrosis may cause perforation or severe bleeding episodes.Primary or metastatic intestinal disease in situ where tumour necrosis may causegastrointestinal perforation.
Use of investigational agent in the 4 weeks or 5 half-lives prior to first dose ofMBS8(1V270), whichever is shortest.
Major surgical procedure within 14 days prior to the first trial drug dose.
Has a history of another primary malignancy, except for:
Malignancy treated with curative intent and with no known active disease within 2 years prior to first dose of MBS8(1V270).
Adequately treated non-invasive basal skin cancer or squamous cell skincarcinoma.
Adequately treated uterine cervical cancer stage 1B or less.
Treatment with systemic immunosuppressive medication (including but not limited tocorticosteroids (>10 mg prednisone per day or equivalent, except topical orinhaled), cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-IL-6receptor agents and anti-TNFα agents) within 2 weeks prior to initiation of trialtreatment, or anticipation of need for systemic immunosuppressive medication duringtrial treatment.
Treatment with androgen deprivation therapies such as luteinizing-hormone releasinghormone (LHRH) (gonadotropin-hormone releasing hormone [GnRH]) agonists within 2weeks prior to initiation of trial treatment.
Ongoing immune-related adverse events (irAEs) and/or AEs ≥ Grade 2 not resolved fromprevious therapies except vitiligo, resolved atopy, limited psoriasis, stableneuropathy Grade 2, hair loss, and stable endocrinopathies with substitutive hormonetherapy.
Has uncontrolled intercurrent or chronic illness, but not limited to, ongoing oractive infection such as hepatitis B or C, human immunodeficiency virus (HIV),immune dysfunction such as autoimmune disease, psychiatric illness such asdepression or suicidal tendency or social situations that would limit compliancewith trial requirements.
Has active or history of immunologic-mediated disease, including but not limited tomyasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus,rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease,antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome orGuillain-Barré syndrome.
Has clinically significant cardiac disease, including:
Known congestive heart failure Grade III or IV by the New York Heart FailureAssociation (see Appendix A);
Myocardial infarction within 6 months prior to signing the ICF;
Onset of unstable angina within 6 months prior to signing the ICF.
History of severe allergic episodes.
Known hypersensitivity to any component of MBS8(1V270).
Has a history of seizure disorders uncontrolled on medication.
Has a history of clinically significant coagulation or bleeding disorders orabnormalities.
Abnormal or clinically significant coagulation parameters at the discretion of theinvestigator, i.e.:
International Normalized Ratio (INR);
Activated Partial Thromboplastin Time (APTT). Subjects being treated withanticoagulants are excluded if the coagulation parameters are outside thetherapeutic intervals as described in the Summary of Product Characteristics (SmPC) for the administered treatment.
Women of childbearing potential who deny remaining abstinent (refrain fromheterosexual intercourse) or do not use a highly effective form of contraceptionthat results in a failure rate of < 1% per year during the treatment period and up 120 days after the last trial drug administration.
Men of reproductive potential who deny to follow accepted contraception methodsduring treatment and up to 120 days after the last trial drug administration.
Pregnant or lactating women.
Has a history or current evidence of any condition, therapy, or laboratoryabnormality that might confound the results of the trial, interfere with thesubject's participation for the full duration of the trial, make administration ofthe trial drugs hazardous, or make it difficult to monitor adverse effects such thatit is not in the best interest of the subject to participate, in the opinion of thetreating investigator.
Has an autoimmune disorder requiring immune modulating treatment (>10 mg prednisoneper day or equivalent, except topical or inhaled) during the last 2 years prior tofirst dose of MBS8(1V270).
Study Design
Study Description
Connect with a study center
Institut Jules Bordet
Anderlecht, 1070
BelgiumActive - Recruiting
University Hospital Leuven
Leuven, 3000
BelgiumSite Not Available
University Hospital of Denmark, Department of Oncology
Copenhagen, DK2100
DenmarkActive - Recruiting
Herlev and Gentofte Hospital, Center for Cancer Research
Herlev, DK-2730
DenmarkActive - Recruiting
Centro Integral Oncológico Clara Campal (CIOCC)
Madrid, 28050
SpainActive - Recruiting
Fundacion Instituto de Investigacion Sanitaria Fundacion Jimenez Diaz (FJD)
Madrid, 28015
SpainActive - Recruiting


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