VB10.NEO + Atezolizumab for Cancer

No longer recruiting at 12 trial locations

Overseen By Ane Stenstroem, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Nykode Therapeutics AS

Must not be taking: Immunostimulants, Immunosuppressants

Disqualifiers: Cardiovascular disease, Liver disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 27 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the combination of VB10.NEO, a new potential drug, and atezolizumab to determine its safety and effectiveness in treating advanced, hard-to-treat cancers. The trial aims to find the right dose and assess how well this combination triggers an immune response and fights tumors. Individuals with cancers such as melanoma, lung, kidney, bladder, or certain other advanced solid tumors that have not responded to standard treatments might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should not have taken systemic immunosuppressive medications or investigational therapy within certain time frames before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of VB10.NEO and atezolizumab is generally safe for patients, meaning most people tolerate the treatment well. Studies have found that it can activate strong and lasting immune responses without causing major side effects. While some minor side effects might occur, they are usually manageable. These results come from earlier research where patients received different doses of this treatment combination. For those considering joining a trial, this information suggests that the treatment has been safely tested in people before. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about VB10.NEO in combination with Atezolizumab because it represents a novel approach in immunotherapy for cancer. Unlike traditional treatments that often focus on directly attacking cancer cells, VB10.NEO is a personalized cancer vaccine designed to stimulate the patient's immune system to recognize and fight cancer cells more effectively. This treatment is combined with Atezolizumab, an immune checkpoint inhibitor, which helps to unleash the immune response by blocking a pathway that cancers use to hide from the immune system. By targeting the cancer in a more personalized manner and enhancing the body's natural defenses, this combination has the potential to provide a more effective and tailored treatment option for cancer patients.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that VB10.NEO, when combined with atezolizumab, leads to strong and lasting immune responses in patients with advanced cancers. In earlier studies, about 64% of patients responded to this combination treatment. The treatment is considered safe, with only a few serious side effects reported. Atezolizumab is already known to help the immune system attack cancer cells and effectively treats several types of cancer. This trial will test different dosages of VB10.NEO with atezolizumab, suggesting that this combination could be promising for treating various solid tumors. ^{1 2 3 6 7}

Who Is on the Research Team?

Siri Torhaug, MD

Principal Investigator

Nykode Therapeutics ASA

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that have worsened after standard therapy or for whom standard therapy isn't suitable. Participants must be expected to live at least 6 months, have good organ function, and an ECOG Performance Status of 0 or 1. They should not be pregnant or breastfeeding and must agree to use effective contraception.

Inclusion Criteria

Ability to comply with the trial protocol

Platelet count 100-450 × 109/L (100,000 - 450,000/µL)

Negative serum pregnancy test for female subjects of childbearing potential

Exclusion Criteria

Positive HIV-1 test

Prior transplantation

QTcF >470ms

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VB10.NEO in combination with Atezolizumab. VB10.NEO is administered by IM injection for an induction course Q3W (4 doses) followed by maintenance doses Q6W (6 doses) and Q12W (5 doses). Atezolizumab is administered by IV infusion on Day 1 of 21-day cycles.

Up to 27 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in vital signs and clinical laboratory parameters.

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term to further assess safety and efficacy.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• VB10.NEO

Trial Overview The trial is testing VB10.NEO in combination with Atezolizumab to see how safe it is, how the body responds, and if it can shrink tumors. It's a phase 1b study where doses are increased gradually (dose-escalation) to find the right dose for future studies.

How Is the Trial Designed?

Group I: VB10.NEO 9 mg in combination with Atezolizumab 1200 mg Experimental Treatment 1 Intervention

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.

Group II: VB10.NEO 6 mg in combination with Atezolizumab 1200 mg Experimental Treatment 1 Intervention

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.

Group III: VB10.NEO 3 mg in combination with Atezolizumab 1200 mg Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Nykode Therapeutics AS

Lead Sponsor

Trials

5

Recruited

220+

Nykode Therapeutics ASA

Lead Sponsor

Trials

7

Recruited

270+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Vaccibody AS

Industry Sponsor

Trials

5

Recruited

220+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.2639

Induction of neoantigen-specific immune responses by ... VB10.NEO combined with atezolizumab demonstrated a favorable safety profile while eliciting robust, durable immune responses across all dose levels.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05018273

NCT05018273 | Study of VB10.NEO in Combination With ... A phase 1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, antigen-specific immune response and preliminary ...

3. trial.medpath.com trial.medpath.com/clinical-trial/ea61a83d15e88366/nct05018273-safety-study-vb10-neo-atezolizumab-tumors

Study of VB10.NEO in Combination With Atezolizumab in ... A phase 1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, antigen-specific immune response and preliminary ...

4. nykode.com nykode.com/wp-content/uploads/2022/10/221026-Neoantigen-Summit-final-version.pdf

Interim analysis of VB10.NEO a fully individualized cancer ... or atezolizumab was seen in 64% of patients. •. 5 patients (10%) experienced seven TRAEs of grade 3. •. 1 patient (2%) experienced ...

5. researchgate.net researchgate.net/publication/392299896_Induction_of_neoantigen-specific_immune_responses_by_VB10NEO_in_combination_with_atezolizumab_in_heavily_pretreated_patients_with_advanced_solid_tumors_Final_analysis_of_the_phase_1b_VB_N-02_trial

Final analysis of the phase 1b VB N-02 trial. In clinical practice, ICIs have demonstrated durable efficacy and wide-ranging applicability across multiple solid tumors, markedly increasing ...

6. nykode.com nykode.com/wp-content/uploads/2025/01/250108_C-02-publication-FINAL.pdf

Company Announcement Final data from the Phase 2 VB-C-02 trial were published in the peer-reviewed BMJ Journal for ImmunoTherapy of Cancer. • VB10.16 in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11749841/

Safety and efficacy of the therapeutic DNA-based vaccine ... We investigated the safety, efficacy, and immunogenicity of the therapeutic DNA-based vaccine VB10.16 combined with the immune checkpoint inhibitor atezolizumab