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Tests treatment safety and results for Advanced Solid Tumor
Official title Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours
ClinicalTrials.gov ID: NCT04855435
What this study is testing
What is MBS8(1V270)?
MBS8(1V270) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Stage I 1. 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...
- 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...
- Measurable disease according to RECIST v1.1. Previously irradiated lesions were measurable if subsequent progression was documented.
You likely can't join if
- A participant was not eligible for the trial if any of the following applied. Stage I Exclusion Criteria
- Have had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy within 4 weeks prior to Screening (6 weeks required for nitrosourea...
- Metastatic disease that involved major airways or blood vessels or centrally located mediastinal tumour masses of large volume with close relation to...
- 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:
See the full eligibility criteria
Who can join
- Stage I 1. 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...
- 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...
- 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...
- Ability to understand and sign the ICF. Stage II General The following general apply to all participants unless cohort criteria specify otherwise.
- Male and female aged ≥18 years.
- Eastern Cooperative Oncology Group performance status 0 to 1.
- Life expectancy ≥3 months as assessed by the Investigator.
- Adequate organ function within 7 to 14 days prior to Day 1. Absolute neutrophil count ≥1.5×10⁹/L; platelets ≥100×10⁹/L; haemoglobin ≥9 g/dL (transfusion allowed per site's policy) Aspartate transaminase/ALT ≤3×ULN...
- Total bilirubin ≤1.5×ULN (≤3×ULN in case of Gilbert's syndrome)
- Creatinine clearance ≥50 mL/min (Cockcroft-Gault or measured)
- International normalised ratio (INR)/activated partial thromboplastin time (APTT) within institutional limits (unless on stable anticoagulation).
- Prior systemic anti-cancer therapy with a washout period of ≥14 days plus resolution of drug-related AEs before C1D1. Participants should have recovered from prior therapy-related toxicities to Baseline or Grade ≤1...
- Major surgery ≥4 weeks, palliative radiotherapy ≥2 weeks, stereotactic body radiation therapy to lung/liver ≥3 weeks.
- No systemic steroids \>10 mg/day prednisone-equivalent within 14 days before C1D1. Note: Physiologic/replacement doses (e.g., adrenal insufficiency) up to 10 mg/day prednisone-equivalent, topical, inhaled...
- All participants of childbearing potential (defined as \<2 years after last menstruation or not surgically sterile) must have a negative highly sensitive pregnancy test at Screening (urine/serum) and agree to use highly...
- Ability to provide informed consent and comply with trial procedures.
- Lactate dehydrogenase ≤2.0×ULN at Screening (single repeat allowed, if confounded). Stage II - Cohort A (Cutaneous Melanoma; Pembrolizumab in Combination with MBS8(1V270)) Specific The following apply specifically to...
- With documented SD lasting ≥6 months, or any CR or PR
- RECIST v1.1 progression on tebentafusp.
- Washout ≥14 days from the last tebentafusp dose, tebentafusp-related AEs recovered to Grade ≤1/Baseline.
- No new organ crisis (e.g., hepatic failure risk, spinal cord compromise) in the prior 4 weeks.
- No escalation of corticosteroids for tumour-related symptoms within 14 days. 13B. Prior exposure to pembrolizumab, nivolumab, or nivolumab + ipilimumab with documented SD lasting ≥6 months, or any CR or PR followed by...
What rules you out
- A participant was not eligible for the trial if any of the following applied. Stage I Exclusion Criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- Had clinically significant cardiac disease, including:
- Known congestive heart failure Grade III or IV by the New York Heart Failure Association (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).
- Had a history of seizure disorders uncontrolled on medication.
- Had a history of clinically significant coagulation or bleeding disorders or abnormalities.
- Abnormal or clinically significant coagulation parameters (i.e., INR and APTT) at the discretion of the Investigator. Participants treated with anticoagulants were excluded if the coagulation parameters were outside the...
- Women of childbearing potential who denied remaining abstinent (refrain from heterosexual intercourse) or did not use a highly effective form of contraception that resulted in a failure rate of \<1% per year during the...
- Men of reproductive potential who denied following accepted contraception methods during the Treatment and up to 120 days after the last trial drug administration.
- Pregnant or lactating women.
- Had a history or current evidence of any condition, therapy, or laboratory abnormality that might have confounded the results of the trial, interfered with the participant's participation for the full duration of the...
- Had an autoimmune disorder requiring immune-modulating treatment (\>10 mg prednisone per day or equivalent, except topical or inhaled) during the last 2 years prior to the first dose of MBS8(1V270). Stage II General...
- Uncontrolled intercurrent illness: active infection requiring IV therapy, uncontrolled congestive heart failure, unstable angina, significant arrhythmia, recent myocardial infarction (≤6 months), or uncontrolled...
- Known active HIV with uncontrolled viraemia, active hepatitis B virus (HBV)/hepatitis C virus (HCV) with high viral load (HBV \>20,000 IU/mL and HCV \>800,000 IU/mL) despite therapy (enrol per local guidelines, if...
- Pregnant or breastfeeding.
- Second malignancy requiring active therapy (except adequately treated non-melanoma skin cancers, in situ cancers, or malignancies in remission ≥2 years)
- Allergy/hypersensitivity to trial drug components.
- Live vaccines within 28 days prior to C1D1.
- QTcF \>500 ms.
- Any condition that, in the Investigator's judgement, compromises safety or compliance.
- Active autoimmune disease requiring systemic treatment in the past 2 years (topicals/inhaled/physiologic replacement allowed).
- Any prior exposure to systemic or IT immunotherapy (except tebentafusp, pembrolizumab, nivolumab, ipilimumab, and relatlimab), but including Montanide, TLR7, TLR8, and TLR9 agonists, polyinosinic:polycytidylic acid...
- Participants who have been previously treated with experimental anti-cancer vaccines. Stage II - Cohort A (Cutaneous Melanoma; Pembrolizumab in Combination with MBS8(1V270)) Specific Exclusion Criteria The following...
The study team makes the final eligibility decision.
Where it's taking place
- Herlev, Denmark
- Barcelona, Spain
- Madrid, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herlev, Denmark; Barcelona, Spain; Madrid, Spain; Valencia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.