E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
advanced adenocarcinoma of the stomach or the lower esophagus |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001173 |
E.1.2 | Term | Adenocarcinoma of esophagus |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001150 |
E.1.2 | Term | Adenocarcinoma gastric |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- Determine antitumoral activity of IMAB362 as monotherapy in patients with metastatic, refactory or recurrent disease of advanced adenocarcinoma of the stomach or the lower esophagus proven by histology |
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E.2.2 | Secondary objectives of the trial |
- Determine profile of adverse effects, safety and tolerability of repeated application - Determine pharmacokinetics and immunogenicity after repeat dosing |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Metastatic, refractory or recurrent disease of advanced adenocarcinoma of the stomach or the lower esophagus proven by histology, - CLDN18.2 expression of the biopsy material from the cancer with at least 50 % with at least 2 + (double intensity) staining intensity confirmed by immunohistochemistry, - At least 1 measureable site of disease according to RECIST criteria (CT scans or MRI not older than 2 weeks before visit 2), - Age ≥ 18 years, - Informed consnet, - ECOG performance status (PS) 0-1 or Karnofsky INdex 70-100% - Life expectancy > 3 months, - Platelet count ≥ 100,000/mm³, - Hemoglobin ≥ 10 g/dl, - Bilirubin normal, - AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present), - Creatinine < 1.5 x ULN, - For women eith childbearing potential (last menstruation less than 2 years prior to enrolment): Negative pregnancy test (β-HCG) at baseline and using two highly effective methods of contraception during the treatment phase and for 8 weeks after the last infusion of the study drug, - Male patients whose sexual partners are women of child bearing potential must use an accepted contraceptive method during the treatment phase and for 8 weeks after the last infusion of the study drug. |
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E.4 | Principal exclusion criteria |
Patients meeting any one or more of the following exclusion criteria are not eligible for study entry: - Pregnancy or breastfeeding, - Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies, - Less than 3 weeks sinde prior chemo- or radiation therapy, - Other investigational agents or devices concurrently or within 4 weeks prior to this study, - Other concurrent anticancer therapies (not for the indication under study treatment), - known HIV infection or known active hepatitis (A, B, C), - Concurrent anticoagulation with vitamin K antagonists (e. g. Coumadin, Marcumar), - Therapeutic doses of heparin (prophylactic doses are accepted), - Uncontrolled illness including, but nor limited to, any of the following: -- Ongoing or active infection requiring parenteral antibiotics -- Symptomatic congestive heart failure -- Unstable angina pectoris -- Uncontrolled hypertension -- Clinically significant cardiac arrhytmia -- Myocardial infarction within the past 6 months -- Gastric bleeding within last four weeks -- Symptomatic peptic ulcer -- Clinical symptoms of cerebral metastasis or documented metastasis -- Psychiatric illness -- situations that would preclude study compliance |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of remission (CR, PR) (RECIST Criteria), Evaluation of antitumoral activity by CT or MRI before start of therapy and after week 10 and week 16. Patients receiving continued treatment will be evaluated by CT or MRI in 8-12 weeks intervals until 6 month after last infusion. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject is the end of the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 17 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 17 |
E.8.9.2 | In all countries concerned by the trial days | 0 |