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Cancer Vaccine
Ad/MAGEA3, MG1-MAGEA3 and pembrolizumab for Non-Small Cell Lung Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Turnstone Biologics, Corp.
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 7 months
Awards & highlights
No Placebo-Only Group
Summary
This is a Phase 1/2, multi-center, open-label, dose-escalation trial of Ad-MAGEA3 and MG1-MAGEA3 in combination with pembrolizumab in patients with Non-Small Cell Lung Cancer who have completed a first standard therapy with at least 1 cycle of platinum based chemotherapy and/or at least one treatment of PD-1 or PD-L1 antibody targeted therapy.
Eligible Conditions
- Non-Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1 - Toxicity as measured by adverse events
Phase 2 - Objective tumour response rate (ORR) based on RECIST v1.1
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: Ad/MAGEA3, MG1-MAGEA3 and pembrolizumabExperimental Treatment3 Interventions
Ad-MAGEA3 prime will be administered as a single IM dose on Day 1 at 2 x 10e11 VP.
MG1/MAGEA3 boost will be administered IV on Day 15 and Day 18 by 5 cohorts: Cohort 1: Days 15 \& 18 at 1x 10e10 pfu.
Cohort 2: Days 15 \& 18 at 1x 10e11 pfu. Cohort 3: Day 15 at 1 x 10e11 pfu; Day 18 at 3 x 10e11 pfu. Cohort 4: Day 15 at 1 x 10e11 pfu; Day 18 at 3 x 10e11 pfu. Cohort 5: Day 15 at 3x 10e11 pfu; Day 18 at 3 x 10e12 pfu. Pembrolizumab will be administered IV every 3 weeks starting on Day 22.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Astuprotimut-R
Not yet FDA approved
Pembrolizumab
FDA approved
Astuprotimut-R
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Turnstone Biologics, Corp.Lead Sponsor
6 Previous Clinical Trials
135 Total Patients Enrolled
Caroline Breitbach, PhDStudy DirectorTurnstone Biologics, Corp.
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