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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.

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.

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.

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

VB10.NEO

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).

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

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

Identify a recommended phase 2 dose (RP2D) and regimen for VB10.NEO in combination with atezolizumab by evaluating the relationship between VB10.NEO dose and safety, biomarker, and antitumor activity endpoints

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

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)

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

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

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

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

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

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

Serum concentration of atezolizumab at specified timepoints

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors	NCT05018273	Solid Tumors, A...	VB10.NEO	18 Years -	Nykode Therapeutics ASA
Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors	NCT05018273	Solid Tumors, A...	VB10.NEO	18 Years -	Nykode Therapeutics ASA

Spots Global Cancer Trial Database for locally advanced and metastatic tumors