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

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

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

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