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Live Biotherapeutic Product

MRx0518 for Pancreatic Cancer

Phase 1

Waitlist Available

Led By Cullen M Taniguchi, MD

Research Sponsored by 4D pharma plc

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 up to 1 year post completion of radiation

Awards & highlights

Study Summary

This trial is testing a new drug, MRx0518, to see if it is safe and effective in treating pancreatic cancer. The drug will be given to patients for one week before they start radiation therapy, during radiation, and until they have surgery to remove the tumor.

Eligible Conditions

Pancreatic Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post completion of radiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year post completion of radiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post completion of radiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To assess the safety of MRx0518 in combination with hypofractionated preoperative radiation through the collection of adverse events

Secondary outcome measures

Distant Control

Local Control

Major pathologic response

+4 more

Other outcome measures

Changes in Circulating Tumour Cells

Changes to microbiome

Genomic changes

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: MRx0518 with hypofractionated preoperative radiationExperimental Treatment2 Interventions

Subjects will take one capsule of MRx0518 twice daily from one week prior to radiation therapy until surgical resection (6 to 9 weeks approx.) Radiation therapy will be delivered as 30Gy/10 fractions over 2 weeks.

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Who is running the clinical trial?

4D pharma plcLead Sponsor

8 Previous Clinical Trials

601 Total Patients Enrolled

Cullen M Taniguchi, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has MRx0518 received regulatory approval from the FDA?

"Due to limited pre-clinical data, MRx0518 was given a rating of 1 on the safety scale. This is indicative that this Phase 1 trial needs further study before its efficacy can be confirmed."

Answered by AI

Are there still vacancies available for this investigation?

"Unfortunately, this clinical trial is not accepting applicants at the moment. It was uploaded to ClinicalTrials.gov on December 20th 2019 and last updated on July 5th 2022; however, there are 698 other studies that participants can take part in right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Live Biotherapeutic Product MRx0518 With Hypofractionated Radiation Therapy in Resectable Pancreatic Cancer

2019. "A Study of Live Biotherapeutic Product MRx0518 With Hypofractionated Radiation Therapy in Resectable Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04193904.