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Solid Tumors, AdultPhase 1NCT05018273

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

A Phase 1 study testing VB10.NEO in people with Solid Tumors, Adult, run by Nykode Therapeutics ASA at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors, Adult
What is being tested?
VB10.NEO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
12 sitesin 3 countries
Study dates
21 Dec 2021to 9 Oct 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

United States5 sites

  • MD Andersson

    Houston, Texas, 77030

  • Norton Cancer Institute

    Louisville, Kentucky, 40202-1840

  • Yale Cancer Institute

    New Haven, Connecticut, 06551

  • The Regents of the University of California

    San Francisco, California, 94143

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

Spain5 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitario Vall d'Hebron

    Barcelona

  • Hospital General Universitario Gregorio Marañón

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Virgen de la Victoria, Campus Universitario De Teatinos s/n

    Málaga, MA

Other trials in Spain

Germany2 sites

  • Charité-Universitätsmedizin Berlin

    Berlin, 10117

  • Nationales Centrum für Tumorerkrankungen (NCT)

    Heidelberg

Other trials in Germany

About this study

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

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).

Being tested
VB10.NEO
Keywords
Locally advanced and metastatic tumors
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VB10.NEOBiological

    Also called Atezolizumab, Tecentriq

    The personalized vaccine VB10.NEO vaccine is given in combination with the PD-L1 inhibitor atezolizumab.

Study groups in NCT05018273
Study groupRoleWhat they receive
VB10.NEO 3 mg in combination with Atezolizumab 1200 mgExperimentalVB10.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.
Receives: Biological: VB10.NEO
VB10.NEO 6 mg in combination with Atezolizumab 1200 mgExperimentalVB10.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.
Receives: Biological: VB10.NEO
VB10.NEO 9 mg in combination with Atezolizumab 1200 mgExperimentalVB10.NEO 9 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.
Receives: Biological: VB10.NEO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events (AEs)

    The number and percentage of participants that experience an adverse event (AE)

    Measured: From baseline and up to 27 months

  2. Changes from baseline in vital signs

    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)

    Measured: From baseline and up to 27 months

  3. Changes from baseline in clinical laboratory parameters

    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

    Measured: From baseline and up to 27 months

Secondary outcomes (7)

  1. Assessment of the antigen-specific immune response elicited by VB10.NEO administered in combination with atezolizumab

    Number and magnitude of antigen-specific T-cell responses before and after initiation of trial treatment

    Measured: From baseline and up to 25 months

  2. Objective response rate (ORR)

    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

    Measured: From baseline and up to 27 months

  3. Duration of response (DOR)

    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

    Measured: From baseline and up to 27 months

  4. Progression free survival (PFS)

    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

    Measured: From baseline and up to 27 months

  5. Overall survival (OS)

    The time from the first trial treatment to death from any cause

    Measured: From baseline and up to 27 months

  6. Characterize the pharmacokinetic of atezolizumab when administered in combination with VB10.NEO.

    Serum concentration of atezolizumab at specified timepoints

    Measured: From baseline and up to 25 months

  7. Evaluate the immune response to atezolizumab when administered in combination with VB10.NEO

    Prevalence of antidrug antibodies (ADAs) to atezolizumab at baseline and incidence of ADAs to atezolizumab

    Measured: From baseline and up to 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2021
  2. Study start21 Dec 2021
  3. Primary completion9 Oct 2024
  4. Study completion9 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05018273
Sponsor's protocol ID
VB N-02
Status last verified
Nov 2024
First submitted
13 Jul 2021
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VB10.NEO in people with Solid Tumors, Adult, run by Nykode Therapeutics ASA at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (AEs) (time frame: From baseline and up to 27 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05018273.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.

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