Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumors, Adult

In brief

A phase 1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, antigen-specific immune response and preliminary antitumor activity associated with VB10.NEO administered in combination with atezolizumab, and to identify a RP2D for VB10.NEO in combination with atezolizumab, in patients with locally advanced and metastatic tumors that have progressed after at least 1 available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care (SOC).

Key facts

Study ID

NCT05018273

Run by

Nykode Therapeutics ASA

People needed

26

Starts

2021-12-21

Expected to finish

2024-10-09

Last updated by the study team

2024-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Tumor types: melanoma, NSCLC, RCC, UC, HNSCC, TNBC, gastric/GEJ cancer, cervical, anal, or MSI-high tumors. Additionally up to 15 subjects with other locally advanced or metastatic solid tumor types not listed above.
• Signed Informed Consent Form
• Age ≥18 years at time of signing the Informed Consent Form
• Ability to comply with the trial protocol
• ECOG Performance Status of ≤ 1: Note: If ECOG Performance Status at Screen 2B assessment was performed > 7 days prior to VB10.NEO start date, it needs to be re-assessed on C1D1 prior to administration of VB10.NEO and remain ≤ 1
• GRIm score ≤ 1 at Screen 1, this only applies for subjects initially screened under protocol version 5
• Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 7 days prior to initiation of trial treatment:
• ANC ≥1.5 × 109/L (1500/µL) Must be met without administration of growth factors within 2 weeks prior to treatment start date.
• Lymphocyte count ≥0.5 × 109/L (500/µL)
• Platelet count 100-450 × 109/L (100,000 - 450,000/µL) Must be met without administration of platelet transfusion within 2 weeks prior to treatment start date.
• Hemoglobin ≥90 g/L (9 g/dL) Must be met without erythropoietin dependency and without red blood cell transfusion within 2 weeks prior to treatment start date.
• AST and ALT ≤3 × ULN
• Alkaline phosphatase (ALP) ≤2.5 × ULN, with the following exceptions:
• Subjects with documented liver or bone metastases: ALP ≤5 × ULN
• Total bilirubin ≤1.5 × ULN with the following exception:
• Subjects with known Gilbert disease: total bilirubin ≤3 × ULN
• Measured or calculated creatinine clearance ≥50 mL/min (according to the Cockcroft-Gault formula)
• Albumin ≥25 g/L (2.5 g/dL)
• For subjects not receiving therapeutic anticoagulation: International Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN
• For subjects receiving therapeutic anticoagulation: stable anticoagulant regimen
• Female subjects of childbearing potential must have a negative serum pregnancy test result within 72 hours prior to initiation of trial treatment.
• Female subjects of childbearing potential must agree to use a highly effective form of contraception during treatment and for at least 90 days after the final dose of VB10.NEO, and for 5 months after the final dose of atezolizumab, whichever occurs later. Highly effective forms of contraception include:
• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
• progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
• intrauterine device

You may not qualify if…

• Pregnant or breastfeeding, or intending to become pregnant during the trial or within 90 days after the last dose of VB10.NEO or 5 months after the last dose of atezolizumab, whichever occurs later
• Significant cardiovascular disease such as, but not limited to, New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina
• QT interval corrected through use of Fridericia's formula (QTcF) >470ms demonstrated by at least 2 electrocardiograms (ECGs) >30 minutes apart
• Clinically significant liver disease including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse
• Positive hepatitis B surface antigen (HBsAg) test at screening
• Subjects with past or resolved hepatitis B infection (defined as having a negative HBsAg test and a positive IgG antibody to hepatitis B core antigen) are eligible.
• Positive hepatitis C virus (HCV) antibody test at screening
• Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA)
• Positive human immunodeficiency virus (HIV)-1 test at screening
• Active tuberculosis
• Any other diseases, metabolic dysfunction, physical examination finding, and/or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or may render the subject at high risk from treatment complications
• Known primary immunodeficiencies
• Active, or history of, autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
• Subjects with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the trial.
• Subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the trial.
• Subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the trial provided all of the following conditions are met:
• Rash must cover <10% of body surface area
• Disease is well controlled at baseline and requires only low potency topical corticosteroids
• No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months
• History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
• Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation.
• Known allergy or hypersensitivity to any component of the VB10.NEO formulation.
• History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on imaging conducted for tumor assessment at screening
• History of radiation pneumonitis in the radiation field (fibrosis) is permitted
• History of drug-induced pneumonitis that was asymptomatic (defined by radiographic findings only) and reversible (without any anti-inflammatory therapies) is permitted.

Where it is running

• The Regents of the University of California — San Francisco, California, United States
• Yale Cancer Institute — New Haven, Connecticut, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Washington University — St Louis, Missouri, United States
• MD Andersson — Houston, Texas, United States
• Charité-Universitätsmedizin Berlin — Berlin, Germany
• Nationales Centrum für Tumorerkrankungen (NCT) — Heidelberg, Germany
• Hospital Universitario Virgen de la Victoria, Campus Universitario De Teatinos s/n — Málaga, MA, Spain
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
• Hospital Universitario Vall d'Hebron — Barcelona, Spain
• Hospital General Universitario Gregorio Marañón — Madrid, Spain
• Hospital Universitario La Paz — Madrid, Spain

Full record on ClinicalTrials.gov

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