TILT-123 + Avelumab for Melanoma (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

No Placebo-Only Group

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2017

Completed Phase 2

~2440

Do I qualify?Apply below to find out