Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-… (NCT01671774) | Clinical Trial Compass
CompletedPhase 1
Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer
Germany, Latvia29 participantsStarted 2012-10-16
Plain-language summary
The purpose of the trial is to assess the immunological effects and their kinetics, the safety and activity of IMAB362 plus Zoledronic acid with/without low to intermediate doses of Interleukin-2 in subjects with advanced gastroesophageal cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction
* Inoperable locally advanced disease, resections with R0, R1 or R2 outcome or metastatic disease.
* CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample.
* Measurable and/or non-measurable disease as defined according to RECIST v1.1
* Age ≥ 18 years
* Written informed consent
* ECOG performance status (PS) 0-1
* Life expectancy \> 3 months
Exclusion Criteria:
* Prior hypersensitivity reaction or intolerance to one of the compounds of the study treatment
* Known HIV infection or known symptomatic hepatitis (A, B, C)
* Clinical symptoms of cerebral metastases
* Pregnancy or breastfeeding
* Patients treated with any bisphosphonate-based therapeutic for any indication during the previous year
* Hypocalcemia that requires medication. Corrected (adjusted for serum albumin) serum calcium \< 8 mg/dl (2 mmol/L) or \> 12 mg/dL (3.0 mmol/L)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.