VB10.NEO + Atezolizumab for Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Nykode Therapeutics AS

No Placebo Group

Breakthrough Therapy

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

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Exclusion Criteria

Positive HIV-1 test

Prior transplantation

QTcF >470ms

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Treatment Details

Interventions

VB10.NEO (Cancer Vaccine)

Trial OverviewThe 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

3Treatment groups

Experimental Treatment

Group I: VB10.NEO 9 mg in combination with Atezolizumab 1200 mgExperimental Treatment1 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 mgExperimental Treatment1 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 mgExperimental Treatment1 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.