Description:
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.
Title
- Brief Title: A Study of Live Biotherapeutic Product MRx0518 With Hypofractionated Radiation Therapy in Resectable Pancreatic Cancer
- Official Title: A Safety and Preliminary Efficacy Study of the Oral Live Biotherapeutic MRx0518 With Hypofractionated Preoperative Radiation for Resectable Pancreatic Cancer
Clinical Trial IDs
- ORG STUDY ID:
MRx0518-I-003
- NCT ID:
NCT04193904
Conditions
Interventions
Drug | Synonyms | Arms |
---|
MRx0518 | | MRx0518 with hypofractionated preoperative radiation |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
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 |
Safety Issue: | |
Description: | Adverse events will be assessed as per CTCAE v5.0 |
Secondary Outcome Measures
Measure: | Major pathologic response |
Time Frame: | At time of surgery |
Safety Issue: | |
Description: | Major pathologic response is defined as <5% viable cells in resected tumour specimen |
Measure: | Tumour infiltrating lymphocytes (TILs) |
Time Frame: | Baseline to Surgery |
Safety Issue: | |
Description: | Changes in TILs from optional baseline biopsy to resected tumour specimen will be assessed. |
Measure: | Overall Survival (OS) |
Time Frame: | 12 months post radiation |
Safety Issue: | |
Description: | OS is defined as the duration from the start of study treatment until death due to any cause |
Measure: | Progression Free Survival (PFS) |
Time Frame: | 12 months post radiation |
Safety Issue: | |
Description: | PFS is defined as the duration from the start of study treatment until disease progression or death |
Measure: | Local Control |
Time Frame: | 6 months post radiation |
Safety Issue: | |
Description: | Local control is defined as absence of progression at the primary site and will be assessed with imaging |
Measure: | Distant Control |
Time Frame: | 6 months post radiation |
Safety Issue: | |
Description: | Distant control is defined as absence of progression at any site other than the primary site and will be assessed with imaging |
Measure: | Margin status |
Time Frame: | At time of surgery |
Safety Issue: | |
Description: | The margin status of the tumour at the time of surgery will be assessed |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | 4D pharma plc |
Last Updated
May 24, 2021