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Ad-MAGEA3

Phase 1

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

Success Probability

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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 CancerUnlock trial analytics

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 387 trials

Frequently asked questions about Ad-MAGEA3

What is Ad-MAGEA3 used for?

Ad-MAGEA3 is an investigational therapy being studied for the treatment of Non-Small Cell Lung Cancer. It is currently in Phase 1 clinical development and is not yet approved for any use.

Who makes Ad-MAGEA3?

Ad-MAGEA3 is being developed by Turnstone Biologics Corp., a biopharmaceutical company. The company's stock is traded under the ticker symbol TSBX.

What phase is Ad-MAGEA3 in?

Ad-MAGEA3 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is Ad-MAGEA3 in?

Ad-MAGEA3 has been studied in one clinical trial, NCT02879760. This was a Phase 1 study in Canada that evaluated the drug in combination with pembrolizumab for patients with Non-Small Cell Lung Cancer. The trial enrolled 16 participants and has been completed.

Is Ad-MAGEA3 the same as MG1-MAGEA3?

Ad-MAGEA3 is a distinct investigational therapy from MG1-MAGEA3. In a clinical trial, Ad-MAGEA3 was studied in combination with MG1-MAGEA3 and pembrolizumab for Non-Small Cell Lung Cancer.