Pancreatic CancerPhase 1NCT04193904
A Study of Live Biotherapeutic Product MRx0518 With Hypofractionated Radiation Therapy in Resectable Pancreatic Cancer
A Phase 1 study testing MRx0518 and Hypofractionated Preoperative Radiation in people with Pancreatic Cancer, run by 4D pharma plc at 1 site in United States.
Trial summary
This is a single center, open-label, phase I study to evaluate the safety and preliminary efficacy of MRx0518 with preoperative hypofractionated radiation in 15 patients with resectable pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- MRx0518 and Hypofractionated Preoperative Radiation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2019to 8 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has signed informed consent and is willing to comply with the protocol
- Cytologic or biopsy confirmed adenocarcinoma of the pancreas
- TNM stage: Tx, T1-4, N0-1 or Nx, M0
- Potentially resectable pancreatic cancer defined as no extra-pancreatic disease, no evidence of tumor extension to the celiac axis, common hepatic artery and superior mesenteric artery, and no evidence of deformity of the superior mesenteric vein or superior mesenteric portal vein confluence
- No evidence of distant metastases either prior to or after induction chemotherapy
- Able to comply with instructions required for radiation therapy
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- Age 18 years or older
- Completion of 2-6 months of standard induction chemotherapy (mFOLFIRINOX, gemcitabine and nab-paclitaxel or other)
- Eastern Cooperative Oncology Group Score 0, 1 or 2
- Adequate haematologic function (absolute neutrophil count ≥1500mm3; haemoglobin ≥8.0 g/dL; platelet count ≥50000mm3)
- Adequate renal and liver function (creatinine ≤ 1.5 x upper limit of normal; total bilirubin ≤ 1.5 x upper limit of normal; aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal; alkaline phosphatase ≤ 2.5 x upper limit of normal
Who cannot join
- Prior radiation therapy to the abdomen that would overlap with the treatment field
- Prior surgical resection of pancreatic tumor
- Receiving any approved or investigational anti-cancer agent other than those provided for in this study
- Uncontrolled or active gastric or duodenal ulcer disease within 30 days of dosing
- Residual or ongoing ≥Grade 3 toxicity from chemotherapy
- Contraindication to IV contrast that can't be managed with pre-medication
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- Concurrent participation in another interventional clinical trial or use of another investigational agent within 30 days of consent (concurrent non-interventional trials are eligible)
- Uncontrolled intercurrent illness including but not limited to, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, stroke, or psychiatric illness that would limit compliance with treatment
- Second primary malignancy within the last 5 years, unless treated definitively and/or low risk in the judgement of the treating investigator
- Known history of HIV or active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have history of infection are eligible)
- Known intolerance or hypersensitivity to study drug
- Subjects who are allergic to amoxicillin/clavulanic acid, erythromycin and imipenem
- Female subjects who are breastfeeding
- Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control for the entire study and for 30 days after last dose of MRx0518. A negative pregnancy test must be obtained within 14 days prior to start of treatment
- Male subjects who are unwilling or unable to use an acceptable method of birth control for the entire study period and for 30 days after last dose of MRx0518
- Serious infection requiring systemic therapy
- Use of systemic antibiotics within 2 weeks of start of study treatment
- Has a known inability for intake of oral capsules
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety and Preliminary Efficacy Study of the Oral Live Biotherapeutic MRx0518 With Hypofractionated Preoperative Radiation for Resectable Pancreatic Cancer
This is a single center, open-label, phase I study to evaluate the safety and preliminary efficacy of MRx0518 with preoperative hypofractionated radiation in 15 patients with resectable pancreatic cancer.
Subjects will take MRx0518 daily for one week prior to the start of radiation therapy, throughout radiation and until surgical resection of the tumour.
- Conditions
- Pancreatic Cancer
- Being tested
- MRx0518, Hypofractionated Preoperative Radiation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRx0518Drug
MRx0518 is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The study dosing regimen is one capsule two times per day for the duration of the treatment period.
Hypofractionated Preoperative RadiationRadiation
Radiation will be delivered as 30Gy/10 fractions over two weeks.
| Study group | Role | What they receive |
|---|---|---|
| MRx0518 with hypofractionated preoperative radiation | Experimental | 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. Receives: Drug: MRx0518; Radiation: Hypofractionated Preoperative Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of MRx0518 in combination with hypofractionated preoperative radiation through the collection of adverse events
Adverse events will be assessed as per CTCAE v5.0
Measured: Up to 1 year post completion of radiation
Secondary outcomes (7)
Major pathologic response
Major pathologic response is defined as <5% viable cells in resected tumour specimen
Measured: At time of surgery
Tumour infiltrating lymphocytes (TILs)
Changes in TILs from optional baseline biopsy to resected tumour specimen will be assessed.
Measured: Baseline to Surgery
Overall Survival (OS)
OS is defined as the duration from the start of study treatment until death due to any cause
Measured: 12 months post radiation
Progression Free Survival (PFS)
PFS is defined as the duration from the start of study treatment until disease progression or death
Measured: 12 months post radiation
Local Control
Local control is defined as absence of progression at the primary site and will be assessed with imaging
Measured: 6 months post radiation
Distant Control
Distant control is defined as absence of progression at any site other than the primary site and will be assessed with imaging
Measured: 6 months post radiation
Margin status
The margin status of the tumour at the time of surgery will be assessed
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start20 Dec 2019
- Primary completion8 May 2023
- Study completion8 May 2023
Why it stopped: Sponsor insolvency
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4D pharma plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cullen M Taniguchi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193904
- Sponsor's protocol ID
- MRx0518-I-003
- Status last verified
- Jun 2023
- First submitted
- 12 Nov 2019
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Preliminary Efficacy Study of the Oral Live Biotherapeutic MRx0518 With Hypofractionated Preoperative Radiation for Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04193904
- Acronym / sponsor ID
- MRx0518-I-003
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor insolvency
- Enrolment
- 13 participants (actual)
- Lead sponsor
- 4D pharma plcIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, open-label, phase I study to evaluate the safety and preliminary efficacy of MRx0518 with preoperative hypofractionated radiation in 15 patients with resectable pancreatic cancer.
Subjects will take MRx0518 daily for one week prior to the start of radiation therapy, throughout radiation and until surgical resection of the tumour.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRx0518 with hypofractionated preoperative radiation | Experimental | Drug: MRx0518, Radiation: Hypofractionated Preoperative RadiationSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient has signed informed consent and is willing to comply with the protocol
- Cytologic or biopsy confirmed adenocarcinoma of the pancreas
- TNM stage: Tx, T1-4, N0-1 or Nx, M0
- Potentially resectable pancreatic cancer defined as no extra-pancreatic disease, no evidence of tumor extension to the celiac axis, common hepatic artery and superior mesenteric artery, and no evidence of deformity of the superior mesenteric vein or superior mesenteric portal vein confluence
- No evidence of distant metastases either prior to or after induction chemotherapy
Key exclusion criteria (18 listed)
- Prior radiation therapy to the abdomen that would overlap with the treatment field
- Prior surgical resection of pancreatic tumor
- Receiving any approved or investigational anti-cancer agent other than those provided for in this study
- Uncontrolled or active gastric or duodenal ulcer disease within 30 days of dosing
- Residual or ongoing ≥Grade 3 toxicity from chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRx0518MRx0518 is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The study dosing regimen is one capsule two times per day for the duration of the treatment period. | Drug | MRx0518 with hypofractionated preoperative radiation |
| Hypofractionated Preoperative RadiationRadiation will be delivered as 30Gy/10 fractions over two weeks. | Radiation | MRx0518 with hypofractionated preoperative radiation |
Primary outcome
To assess the safety of MRx0518 in combination with hypofractionated preoperative radiation through the collection of adverse events
Time frame: Up to 1 year post completion of radiation
Adverse events will be assessed as per CTCAE v5.0
7 secondary outcomes
Major pathologic response
Time frame: At time of surgery
Tumour infiltrating lymphocytes (TILs)
Time frame: Baseline to Surgery
Overall Survival (OS)
Time frame: 12 months post radiation
Progression Free Survival (PFS)
Time frame: 12 months post radiation
Local Control
Time frame: 6 months post radiation
Distant Control
Time frame: 6 months post radiation
Margin status
Time frame: At time of surgery
Results and safety
The study was stopped early (reason given: Sponsor insolvency). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cullen M Taniguchi, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRx0518 and Hypofractionated Preoperative Radiation in people with Pancreatic Cancer, run by 4D pharma plc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor insolvency). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of MRx0518 in combination with hypofractionated preoperative radiation through the collection of adverse events (time frame: Up to 1 year post completion of radiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.