Intraoperative Imaging of Colon Cancer Using a Fluorescent Peptide (EMI-137) Against the c-Met Receptor

GS16/87090

EMI-137 in laparoscopic colonic resections is a single-centre stage IIa developmental study. Ten adult participants with a diagnosis of colon adenocarcinoma undergoing laparoscopic colonic will be recruited to the trial. Participants will receive a single intravenous dose of the IMP - EMI-137 1 to 3 hours before surgery. The ability of EMI-137 to produce visible intra-operative fluorescence of primary colon cancer and lymph node metastases will be explored and evaluated.

2018-02-14

2020-02-14

2020-03-14

Completed

Early phase I

10

Inclusion Criteria: * Age ≥ 18 years. * Patients with a diagnosis of colonic cancer (the disease can be of any radiological TMN stage and be located anywhere from the caecum up to but not including the rectosigmoid junction) * Patients with or without distant visceral or lymphatic metastatic disease. * Patients with synchronous colon cancers or polyps can participate. * American Society of Anaesthesiologists (ASA) classification ≤3. * Normal hepatic and renal function (eGFR ≥60 mls/min/1.73m2) and bilirubin within institutional limits and/or ALT ≤2.5x upper limit of institutional normal value) on serum laboratory blood tests performed ≤30 days prior to EMI-137 administration. * Female participants who are surgically sterile (documented bilateral oophorectomy and/or hysterectomy), post-menopausal (cessation of menses for more than 1 year), or pre-menopausal with two negative urine pregnancy tests performed within 24 hours of administration of EMI-137 Injection. * Pre-menopausal female participants of child-bearing potential who agree to employ two method of contraception (as defined in eligibility criteria of the protocol) during the study period and for 90 days after EMI-137 administration. * Male participants with a non-pregnant female partner. Male participants with a pre-menopausal partner of child-bearing potential who agree to use two forms of contraception (as defined in section 8.2) during the study period and for at least 90 days after receiving EMI-137. (The only permissible exception would be if the participant had undergone documented bilateral orchidectomy or their female partner is post-menopausal (cessation menses \>1 year) or has undergone documented bilateral oophorectomy and/or hysterectomy). Exclusion Criteria: * Patients who are participating in another intra-operative fluorescence study, or have participated in another fluorescence study within 3 months of the planned surgical procedure. * Received an investigational medicinal product at any dose within 28 days of planned EMI-137 administration * Patients with pre-existing inflammatory bowel disease. * Patients who have undergone neoadjuvant chemotherapy to treat the colon cancer. * Patients with impaired renal function (eGFR \<60 mls/min/1.73m2). * Patients with impaired liver function (Bilirubin above institutional limits and/or ALT \>2.5x upper limit of normal). * Pregnant and breastfeeding woman. * Pre-menopausal woman planning to become pregnant within 90 days of receiving EMI-137; or pre-menopausal woman of child-bearing potential who refuse to use two forms of contraception for at least 90 days after receiving EMI-137. * Male patients with a currently pregnant partner or male patients who are planning to conceive a pregnancy with a female partner within 90 days of receiving EMI-137; or male participants who refuse to use two forms of contraception as defined in section 8.2 for at least 90 days after receiving EMI-137 with their female partner of child-bearing potential. * Poorly controlled or serious medical or psychiatric illness that, in the investigator's opinion, is likely to interfere with participation and/or compliance in this clinical trial. * Previous adverse reaction to fluorescent agents.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-centre stage IIa developmental study, Open label, single arm, non-randomised feasibility study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

2024-05-08