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Checkpoint Inhibitor
TILT-123 + 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
No Placebo-Only Group
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).
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose Escalation Phase
Incidence of Adverse Events
Secondary study objectives
Dose Escalation Phase MTD
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 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
Find a Location
Who is running the clinical trial?
TILT Biotherapeutics Ltd.Lead Sponsor
4 Previous Clinical Trials
79 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,778 Total Patients Enrolled