Solid Tumors
Conditions
Brief summary
IMAB362 is a monoclonal antibody specific for gastric or lower esophageal adenocarcinoma. Preclinically IMAB362 was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase II study is to establish efficacy and safety of multiple doses of IMAB362 as monotherapy in patients suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the lower esophagus.
Interventions
DRUGIMAB362
Cohort 1 repeated doses of 300 mg/m2 Cohort 2 repeated doses of 600 mg/m2 Cohort 3 doses to be determined, 600mg/m2 or less
Sponsors
Ganymed Pharmaceuticals GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 confirmed by immunohistochemistry * At least 1 measurable site of disease according to RECIST criteria
Exclusion criteria
* Less than 3 weeks since prior chemo-or radiation therapy * Other concurrent anticancer therapies * Concurrent anticoagulation with vitamin K antagonists * Therapeutic doses of Heparin (prophylactic doses accepted) * Uncontrolled or severe illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of remission (CR, PR) according to RECIST Criteria | All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with adverse events as a measure of safety and tolerability | All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion | — |
| Frequency and severity of adverse events according to CTCAE v3.0 | All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion | — |
| Progression-free-survival time (PFS) | All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion | The time from start of the first infusion to date of first observed disease progression or death due to progression (whichever is first) |
Countries
Bulgaria, Germany, Latvia, Lithuania, Switzerland
Outcome results
None listed