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Ad-MAGEA3

Phase 1

Non-Small Cell Lung Cancer | Monoclonal antibody | Oncology |Turnstone Biologics Corp.|Last Updated: Oct 6, 2020

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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical trial landscape

Ad-MAGEA3 · 1 trial · 1 indication

Phase 1 1
NCT02879760Oncolytic MG1-MAGEA3 With Ad-MAGEA3 Vaccine in Combination With Pembrolizumab for Non-Small Cell Lung Cancer PatientsNon-Small Cell Lung Cancer
COMPLETED16 Analytics
PHASE1COMPLETED
Oncolytic MG1-MAGEA3 With Ad-MAGEA3 Vaccine in Combination With Pembrolizumab for Non-Small Cell Lung Cancer Patients
Non-Small Cell Lung Cancer
NCT0287976016
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Study Endpoints
Primary Endpoints
Phase 1 - Toxicity as measured by adverse events
7 months

To determine the maximum tolerated dose MTD/ maximum feasible dose MFD of Ad/MAGEA3 and MG1-MAGEA3 in combination with pembrolizumab

Phase 2 - Objective tumour response rate (ORR) based on RECIST v1.1
7 months

To evaluate objective tumour response rate (ORR) based on RECIST 1.1

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ad/MAGEA3, MG1-MAGEA3 and pembrolizumabEXPERIMENTALAd-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.
Interventions
NameTypeDescription
Ad-MAGEA3BIOLOGICALIntramuscular injection
MG1-MAGEA3BIOLOGICALIntravenous infusion
PembrolizumabBIOLOGICALIntravenous infusion
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: In order to be eligible for participation in this trial, the patient must: 1. Have histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) with positive expression of MAGE-A3 (primary or metastatic lesion). 2. Phase 1: Have radiographic progressi...

Countries:Canada
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Competitive Landscape -Non-Small Cell Lung Cancer 395 trials

Top 20 of 86 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK25PHASE4Pembrolizumab, Olaparib, Etoposide, Carboplatin, Cisplatin
AstraZeneca PLCAZN62PHASE4Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin
Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel
Eli Lilly and CompanyLLY19PHASE4Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE4Telisotuzumab Vedotin, Docetaxel
Amgen Inc.AMGN5PHASE4AMG 510, Docetaxel
Bristol-Myers Squibb CompanyBMY19PHASE4Repotrectinib, Crizotinib
BioNTech SE Sponsored ADRBNTX7PHASE4Gotistobart, Docetaxel
Gilead Sciences, Inc.GILD4PHASE4Sacituzumab Govitecan-hziy, Docetaxel
Johnson & JohnsonJNJ17PHASE4Lazertinib, Amivantamab, Pemetrexed, Carboplatin
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Pfizer Inc.PFE17PHASE4Lorlatinib, Crizotinib
GSK plc Sponsored ADRGSK4PHASE4Dostarlimab, Belrestotug, Pembrolizumab
Novartis AG Sponsored ADRNVS9PHASE4JDQ443, docetaxel
Summit Therapeutics IncSMMT2PHASE4Ivonescimab, Pembrolizumab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE4cemiplimab, Platinum Doublet, fianlimab
BeOne Medicines Ltd. Sponsored ADRONC6PHASE4Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
BeyondSpring Inc.BYSI1PHASE3Plinabulin, Docetaxel
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