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PD-L1 Inhibitor

TILT-123 and avelumab for Head and Neck Squamous Cell Carcinoma (AVENTIL Trial)

Phase 1

Recruiting

Led By Tuomo Alanko

Research Sponsored by TILT Biotherapeutics Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 85 days

Awards & highlights

AVENTIL Trial Summary

This trial is testing the safety of a new treatment called oncolytic adenovirus TILT-123, along with a drug called avelumab, in patients with advanced solid tumors that have

Who is the study for?

This trial is for adults over 18 with certain advanced solid tumors (like melanoma or head and neck cancers) that have stopped responding to standard treatments, including anti-PD(L)1 immunotherapy. Participants need a tumor large enough for biopsy and injection, good liver function, no curative treatment options available, and must have completed prior PD-1/PDL-1 therapy.Check my eligibility

What is being tested?

The study tests TILT-123 (an oncolytic adenovirus) combined with Avelumab in patients whose tumors are not responding to previous therapies. It's an early-phase trial designed to find out the safest dose of TILT-123 when used with Avelumab.See study design

What are the potential side effects?

Possible side effects include typical reactions related to immune therapies such as fatigue, flu-like symptoms, skin reactions at the injection site, allergic responses, and potential changes in blood test results reflecting organ functions.

AVENTIL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 85 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~85 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 85 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Adverse Events assessed by 12- lead electrocardiograms (ECGs)

Number of Participants with abnormal laboratory values.

Number of Participants with any (serious and non-serious) Adverse Events.

+1 more

AVENTIL Trial Design

1Treatment groups

Experimental Treatment

Group I: TILT-123 and avelumabExperimental Treatment2 Interventions

Patients will receive multiple administrations of TILT-123 and avelumab. Escalation to the next dose of TILT-123 level will occur when the safety data has been evaluated for all patients in the preceding dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Avelumab

2018

Completed Phase 2

~2450

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

TILT Biotherapeutics Ltd.Lead Sponsor

4 Previous Clinical Trials

86 Total Patients Enrolled

Tuomo AlankoPrincipal InvestigatorDocrates Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit on the number of participants involved in this medical study?

"Yes, information available on clinicaltrials.gov confirms that recruitment for this medical trial is ongoing. The trial was initially listed on 3/8/2023 and last modified on 3/18/2024. Enrollment targets include 15 participants spread across two locations."

Answered by AI

Are there any available positions for participants in this research study?

"Yes, information on clinicaltrials.gov indicates that this trial is actively enrolling participants. The trial was initially posted on March 8th, 2023 and last modified on March 18th, 2024. There are openings for 15 patients across two locations."

Answered by AI

Has TILT-123 and avelumab received the stamp of approval from the FDA?

"Based on the preliminary analysis conducted by our team at Power, the safety rating for TILT-123 and avelumab is marked as 1. This assessment aligns with Phase 1 trials where there exists restricted evidence supporting both the effectiveness and safety of these pharmaceutical agents."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oncolytic Adenovirus TILT-123 and Avelumab for Treatment of Solid Tumors Refractory to or Progressing After Anti-PD(L)1

2023. "Oncolytic Adenovirus TILT-123 and Avelumab for Treatment of Solid Tumors Refractory to or Progressing After Anti-PD(L)1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05222932.

All > Adenovirus > Immunotherapy