VB10.NEO + Atezolizumab for Cancer

Recruiting at 11 trial locations

Overseen By Ane Stenstroem, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Nykode Therapeutics AS

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

26 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new cancer vaccine combined with a drug that helps the immune system in patients whose cancer has not responded to usual treatments. The vaccine helps the immune system recognize cancer cells, and the drug boosts the immune response to attack these cells more effectively.

Research Team

Siri Torhaug, MD

Principal Investigator

Nykode Therapeutics ASA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+