MRx0518 in Patients With Solid Tumours Waiting Surgical Removal of the Tumour

  • STATUS
    Recruiting
  • End date
    Feb 23, 2022
  • participants needed
    120
  • sponsor
    Imperial College London
Updated on 23 January 2021
cancer
cancer chemotherapy

Summary

The primary objective is to determine the safety and tolerability of the novel compound, MRx0518 in patients with solid tumours at 30 days post-surgery.

20 participants will receive open label MRx0518 in a preliminary safety phase. After successful evaluation by the Independent Safety Monitoring Committee (IDMC), a further 100 participants will be recruited to receive MRx0518/Placebo.

Description

This is a first in human, single centre study in two parts, which aims to determine the safety and tolerability of the novel biotherapeutic compound, MRx0518, to examine its use as an anti-cancer and immune system modulating agent in patients with a range of solid tumours, over 2 years.

MRx0518 is composed of a proprietary strain of bacterium (Enterococcus species) which is found in the gastrointestinal tract of approx. 25% of humans and is predicted, from preclinical studies, to produce beneficial effects in humans.

Patients who have been diagnosed with melanoma, breast, ovarian, uterine, prostate, urethra, bladder, renal, lung or head and neck cancer, who are amenable to surgical resection, will receive MRx0518 (part A) or MRx0518/placebo (part B) orally twice daily for 2-4 weeks until surgery to remove the tumour. In part A, 20 patients will receive open label MRx0518 as part of a preliminary safety assessment. Following surgery, patients will attend a 30 day, 6 month, 12 month and 24 month follow up visit.

Following successful evaluation of part A data by the Independent Data Monitoring Committee (IDMC) the study will continue to recruit a further 100 patients to Part B of the trial. Part B will be placebo controlled, in which patients will be randomised in a double blinded fashion in a 4:1 ratio of MRx0518:placebo. In total, 120 patients will be recruited into the study (20 from part A and 100 from part B).

Details
Condition Malignant neoplasm of prostate, Urethral Cancer, Pulmonary Disease, urinary tract neoplasm, Ovarian disorder, Malignant neoplasm of kidney, Nephropathy, Disorder of uterus NOS, Uterine Cancer, Prostatic disorder, bladder cancer, bladder disorder, Breast Cancer, Ovarian Cancer, melanoma, Lung Neoplasm, skin cancer, Bronchial Neoplasm, head and neck cancer, Metastatic Melanoma, Prostate Disorders, Kidney Disease (Pediatric), Prostate Cancer, Early, Recurrent, Ovarian Function, Breast Cancer Diagnosis, Urothelial Cancer, Recurrent Ovarian Cancer, Kidney Cancer, Lung Cancer, Prostate Cancer, Malignant Melanoma, Kidney Disease, Lung Disease, Bladder Disorders, Uterine Disorders, Renal Cancer, Bladder Carcinoma, Urologic Cancer, breast carcinoma, prostate carcinoma, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, carcinoma of the bladder, cancer, breast, cancer of the head and neck, ovarian tumors, cancer, renal, prostate cancers, bladder tumor, carcinoma lung, lung carcinoma
Treatment MRx0518 Capsules, MRx0518/placebo Capsules
Clinical Study IdentifierNCT03934827
SponsorImperial College London
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

18 years of age or over
Provide written (signed and dated) informed consent and be capable of understanding the study and co-operating with treatment and follow-up
Have radiologically, histologically or cytologically confirmed melanoma, breast, ovarian, uterine, prostate, urethra, bladder, renal, lung, or head and neck cancer _that is considered amenable to primary surgical resection and where primary surgery is planned but would not routinely have been performed until 2-4 weeks post initial biopsy._ New primary cancers or recurrences are permissible provided the patient has not received chemotherapy, radiotherapy or surgery for the last two years prior to screening
Have a life expectancy of greater than 12 weeks
Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Have normal organ and marrow function
Women of child-bearing potential and men must agree to use adequate and highly effective contraception for at least 28 days prior to dosing until one complete menstrual cycle post dosing for women and 3 months after the last dose for men. Alternatively, true abstinence may be used, where this is in line with the preferred and usual lifestyle of the patient
Able to swallow and retain oral medication

Exclusion Criteria

Patients who have had any anti-cancer therapy within the last 2 years
Patients with cancer affecting the gastrointestinal tract or those where bowel resection is considered to be highly likely to be required
Patients may not be receiving any other investigational agents or receiving concurrent anti-cancer therapy. In addition, all herbal (alternative) medicines are excluded
Patients not willing, or for whom it is not planned, to undergo primary surgery for their cancer 2-4 weeks after initiation of therapy with IMP
Patient who would otherwise have undergone primary surgery within 2 weeks of starting therapy with IMP
Patients who have rapidly progressive local disease, or local disease that, in the opinion of the investigator, is not amenable to surgical resection
Patients with known structural or valvular heart valve defects, gastrointestinal fistula, feeding tubes and inflammatory bowel disease or those who are immunosuppressed or receiving immunosuppressant medication (steroids up to an equivalent dose of 20mg of prednisolone daily is allowed as long as the dose has been stable for the last 6 months)
Patients who smoke or use nicotine in any form including e-cigarettes and nicotine patches or sprays or have smoked/used nicotine in the 3 months prior to screening
Patients who consume more than 14 units of alcohol per week, on a regular basis
History of allergic reactions attributed to compounds of similar biologic composition to MRx0518
Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, including patients with active hepatitis B virus (HBV), active hepatitis C virus (HCV) who have a detectable viral load, and patients with Human Immunodeficiency Virus (HIV), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations, gastrointestinal disease that would limit compliance with study requirements
Any significant infection e.g. influenza, fever over 38C, meningitis or an infection resulting in the subject seeking a consultation with a healthcare professional, within four weeks of starting IMP therapy
Pregnant women are excluded from this study because teratogenic or abortifacient effects are unknown. Furthermore, there is an unknown but potential risk for adverse events in nursing infants, secondary to treatment of the mother with MRx0518 so breastfeeding should be discontinued if the mother is treated with MRx0518
Patients with gastrointestinal disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
Patients who have completed a course of antibiotics within the four weeks before dosing
Patients who are allergic to amoxicillin/clavulanic acid, erythromycin and imipenem
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