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Checkpoint Inhibitor

TILT-123 and Pembrolizumab for Lung Cancer

Phase 1

Recruiting

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 day 1 to day 85

Awards & highlights

Study Summary

This trial is testing the safety of a new treatment called oncolytic adenovirus TILT-123 when used together with Pembrolizumab in patients with non-small cell lung cancer that did

Who is the study for?

This trial is for adults with non-small cell lung cancer that's not responding to immune checkpoint inhibitors. They need a tumor big enough for safe biopsy, measurable disease per RECIST 1.1, and good organ function shown by specific blood counts (WBCs >3.0, ANC ≥1500/µL, Platelets ≥100000/µL, Hemoglobin ≥9.0 g/dL).Check my eligibility

What is being tested?

The trial tests TILT-123 (an oncolytic adenovirus) combined with Pembrolizumab in patients whose lung cancer hasn't improved with standard immunotherapy. It's an early-phase study where researchers gradually increase the dose to find the safest level.See study design

What are the potential side effects?

Possible side effects include typical reactions from virus-based therapies like flu-like symptoms and inflammation at injection sites, as well as Pembrolizumab-related issues such as fatigue, skin rash, diarrhea and potential immune system complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 85

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 85

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 85 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Dose Escalation Phase

Incidence of Adverse Events

Secondary outcome measures

Dose Escalation Phase MTD

Trial Design

1Treatment groups

Experimental Treatment

Group I: TILT-123 and PembrolizumabExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

KEYTRUDA®

2018

Completed Phase 2

~70

Do I qualify?Apply below to find out

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Who is running the clinical trial?

TILT Biotherapeutics Ltd.Lead Sponsor

4 Previous Clinical Trials

79 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,124 Total Patients Enrolled

Frequently Asked Questions

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

What is the current total number of participants being recruited for this clinical study?

"Affirmative. The details on clinicaltrials.gov confirm that this investigation is actively enrolling volunteers. Originally listed on March 20, 2024, the study was recently revised on March 21, 2024. It aims to recruit a total of 22 participants from two distinct sites."

Answered by AI

Are there still available openings for new participants in this research study?

"Indeed, the details provided on clinicaltrials.gov affirm that this specific medical study is actively seeking volunteers. It was originally listed on March 20th, 2024 and underwent its most recent update one day later. A total of 22 individuals will be enrolled from two distinct sites."

Answered by AI

Have TILT-123 and Pembrolizumab received approval from the FDA?

"TILT-123 and Pembrolizumab safety rating is designated as 1 by our team at Power on the basis of this being a Phase 1 trial, indicating limited evidence supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer

2024. "Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06125197.

All > Adenovirus