Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors
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ClinicalTrials.gov Identifier: NCT05018273 |
Recruitment Status :
Recruiting
First Posted : August 24, 2021
Last Update Posted : July 13, 2022
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Condition or disease | Intervention/treatment | Phase |
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Solid Tumors, Adult | Biological: VB10.NEO | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1B, Open-Label, Dose-Escalation Study of the Safety of and Antigen-specific Immune Responses Elicited by VB10.NEO in Combination With Atezolizumab in Patients With Locally Advanced and Metastatic Tumors |
Actual Study Start Date : | December 21, 2021 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | December 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: VB10.NEO 3 mg in combination with Atezolizumab 1200 mg
VB10.NEO 3 mg will be administered by IM injection for an induction course Q3W (4 doses) followed by maintenance doses Q6W (6 doses) and Q12W (5 doses). Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of 21 day cycles. |
Biological: VB10.NEO
The personalized vaccine VB10.NEO vaccine is given in combination with the PD-L1 inhibitor atezolizumab.
Other Names:
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Experimental: VB10.NEO 6 mg in combination with Atezolizumab 1200 mg
VB10.NEO 6 mg will be administered by IM injection for an induction course Q3W (4 doses) followed by maintenance doses Q6W (6 doses) and Q12W (5 doses). Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of 21 day cycles. |
Biological: VB10.NEO
The personalized vaccine VB10.NEO vaccine is given in combination with the PD-L1 inhibitor atezolizumab.
Other Names:
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- Incidence and severity of adverse events (AEs) [ Time Frame: From baseline and up to 27 months ]The number and percentage of participants that experience an adverse event (AE)
- Changes from baseline in vital signs [ Time Frame: From baseline and up to 27 months ]Changes for measurements done prior and after the first VB10.NEO injection of each cycle for the following vital signs: Systolic blood pressure (mmHg); diastolic blood pressure (mmHg); pulse rate (bpm); respiration rate (breaths/min); body temperature (°C)
- Changes from baseline in clinical laboratory parameters [ Time Frame: From baseline and up to 27 months ]Changes for clinical laboratory parameters analysed locally prior and after the first VB10.NEO injection of each cycle, including hematology, chemistry panel, coagulation, thyroid function testing, C-reactive protein, urinalysis and serology
- Assessment of the antigen-specific immune response elicited by VB10.NEO administered in combination with atezolizumab [ Time Frame: From baseline and up to 25 months ]Number and magnitude of antigen-specific T-cell responses before and after initiation of trial treatment
- Objective response rate (ORR) [ Time Frame: From baseline and up to 27 months ]The proportion of subjects with a complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Duration of response (DOR) [ Time Frame: From baseline and up to 27 months ]The time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
- Progression free survival (PFS) [ Time Frame: From baseline and up to 27 months ]The time from the first trial treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
- Overall survival (OS) [ Time Frame: From baseline and up to 27 months ]The time from the first trial treatment to death from any cause
- Characterize the pharmacokinetic of atezolizumab when administered in combination with VB10.NEO. [ Time Frame: From baseline and up to 25 months ]Serum concentration of atezolizumab at specified timepoints
- Evaluate the immune response to atezolizumab when administered in combination with VB10.NEO [ Time Frame: From baseline and up to 25 months ]Prevalence of antidrug antibodies (ADAs) to atezolizumab at baseline and incidence of ADAs to atezolizumab
- Dose finding objective [ Time Frame: Through study completion, an average of 2 years. ]Identify a recommended phase 2 dose (RP2D) and regimen for VB10.NEO in combination with atezolizumab by evaluating the relationship between VB10.NEO dose and safety, biomarker, and antitumor activity endpoints

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Tumor types: melanoma, NSCLC, RCC, UC, HNSCC, TNBC, gastric/GEJ cancer, cervical, anal, or MSI-high tumors. Additionally up to 10 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
Life expectancy ≥ 6 months
Ability to comply with the trial protocol
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of trial treatment:
ANC ≥1.5 × 109/L (1500/µL) without granulocyte colony-stimulating factor support
Lymphocyte count ≥0.5 × 109/L (500/µL)
Platelet count ≥100 × 109/L (100,000/µL) without transfusion
Hemoglobin ≥90 g/L (9 g/dL)
Subjects may be transfused to meet this criterion.
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 14 days 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
intrauterine hormone-releasing system
bilateral tubal occlusion
vasectomized partner
sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Periodic abstinence [calendar, symptothermal, post-ovulation methods], withdrawal [coitus interruptus], spermicides only, and the lactational amenorrhea method are not acceptable methods of contraception).
For men with a female partner of childbearing potential or pregnant female partner: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom during the treatment period and for at least 28 days after the final dose of trial treatment to avoid exposing the embryo, and agreement to refrain from donating sperm. Histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has 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 SOC.
Exclusion Criteria:
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 lowpotency 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.
Severe infection within 28 days prior to Cycle 1, Day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease [COPD] exacerbation) are eligible for the trial.
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Subjects with indwelling catheters (e.g., PleurX) are allowed.
Uncontrolled or symptomatic hypercalcemia (ionized calcium >1.5 mmol/L, calcium >12 mg/dL, or corrected calcium >ULN)
Major surgical procedure within 28 days prior to Cycle 1, Day 1, or anticipation of need for a major surgical procedure during the course of the trial
Prior allogeneic stem cell or solid organ transplantation
Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 28 days or 5 drug-elimination half-lives (whichever is longer) prior to Cycle 1, Day 1
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone >7.5 mg/day, cyclophosphamide, azathioprine, methotrexate, thalidomide, and tumor necrosis factor-alpha [TNF-α] antagonists) within 2 weeks prior to Cycle 1, Day 1 with the following exceptions:
Subjects who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the trial after medical monitor confirmation has been obtained
Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for COPD or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the trial.
Treatment with investigational therapy within 28 days prior to Cycle 1, Day 1
Live, attenuated vaccines are prohibited within 28 days prior to Cycle 1, Day 1, during atezolizumab treatment, and for 5 months after the final dose of atezolizumab
Vaccination with an approved COVID-19 vaccine that does not contain live, attenuated virus is permitted

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05018273
Contact: Siri Torhaug, MD | +4795113393 | storhaug@nykode.com | |
Contact: Ane Stenstroem, MSc | astenstroem@nykode.com |
United States, California | |
The Regents of the University of California | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Lawrence Fong, MD | |
United States, Connecticut | |
Yale Cancer Institute | Recruiting |
New Haven, Connecticut, United States, 06551 | |
Contact: Navid Hafez, MD | |
United States, Kentucky | |
Norton Cancer Institute | Recruiting |
Louisville, Kentucky, United States, 40202-1840 | |
Contact: Jaspreet Grewal, MD | |
United States, Missouri | |
Washington University | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Nikolaos Trikalinos, MD | |
United States, Texas | |
MD Andersson | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Siqing FU, MD siqingfu@mdanderson.org | |
Contact: Kathrine Torres KTorres4@mdanderson.org | |
Germany | |
Charité-Universitätsmedizin Berlin | Recruiting |
Berlin, Germany, 10117 | |
Contact: Sebastian Ochsenreither, MD | |
Nationales Centrum für Tumorerkrankungen (NCT) | Recruiting |
Heidelberg, Germany | |
Contact: Juergen Krauss, MD, PhD | |
Spain | |
Hospital Universitario Virgen de la Victoria, Campus Universitario De Teatinos s/n | Recruiting |
Málaga, MA, Spain | |
Contact: Laura Medina Rodriguez, MD | |
Hospital de la Santa Creu i Sant Pau | Recruiting |
Barcelona, Spain, 08025 | |
Contact: Geòrgia Anguera Palacios, MD | |
Hospital Universitario Vall d'Hebron | Recruiting |
Barcelona, Spain | |
Contact: Josep Tabernero, MD, PhD | |
Hospital Universitario La Paz | Recruiting |
Madrid, Spain | |
Contact: Beatriz Castelo, MD |
Responsible Party: | Nykode Therapeutics ASA |
ClinicalTrials.gov Identifier: | NCT05018273 |
Other Study ID Numbers: |
VB N-02 |
First Posted: | August 24, 2021 Key Record Dates |
Last Update Posted: | July 13, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Locally advanced and metastatic tumors |
Neoplasms Atezolizumab Antineoplastic Agents |