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

NCT05018273 | Completed Phase 1 FDA Drug

• 1 other identifier: VB N-02
• Study Type: interventional
• Target: 26
• Locations: 3 countries
• Sites: 12

Brief 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 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).

Conditions

Solid Tumors, Adult

Keywords

Locally advanced and metastatic tumors

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of adverse events (AEs)

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

  From baseline and up to 27 months

• 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)

  From baseline and up to 27 months

• 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

  From baseline and up to 27 months

Secondary Outcomes (7)

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

  From baseline and up to 25 months

• Objective response rate (ORR)

  From baseline and up to 27 months

• Duration of response (DOR)

  From baseline and up to 27 months

• Progression free survival (PFS)

  From baseline and up to 27 months

• Overall survival (OS)

  From baseline and up to 27 months

Other Outcomes (1)

• Dose finding objective

  Through study completion, an average of 2 years.

Study Arms (3)

VB10.NEO 3 mg in combination with Atezolizumab 1200 mg

EXPERIMENTAL

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

VB10.NEO 6 mg in combination with Atezolizumab 1200 mg

EXPERIMENTAL

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

VB10.NEO 9 mg in combination with Atezolizumab 1200 mg

EXPERIMENTAL

VB10.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.

Biological: VB10.NEO

Interventions

VB10.NEO BIOLOGICAL

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

Also known as: Atezolizumab, Tecentriq

VB10.NEO 3 mg in combination with Atezolizumab 1200 mg; VB10.NEO 6 mg in combination with Atezolizumab 1200 mg; VB10.NEO 9 mg in combination with Atezolizumab 1200 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

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.

Sponsors & Collaborators

• Nykode Therapeutics ASA: lead
• Genentech, Inc.: collaborator
• Vaccibody AS: collaborator

Study Sites (12)

The Regents of the University of California

San Francisco, California, 94143, United States

Location

Yale Cancer Institute

New Haven, Connecticut, 06551, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202-1840, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

MD Andersson

Houston, Texas, 77030, United States

Location

Charité-Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, Germany

Location

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

Málaga, MA, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Siri Torhaug, MD

  Nykode Therapeutics ASA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 24, 2021
• Study Start: December 21, 2021
• Primary Completion: October 9, 2024
• Study Completion: October 9, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); US (5); DE (2)