Solid TumorsPhase 2NCT01197885
Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer
A Phase 2 study testing IMAB362 in people with Solid Tumors, run by Ganymed Pharmaceuticals GmbH at 21 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- IMAB362
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 3 Sep 2010to 13 Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
Germany13 sites
Charité - Universitätsmedizin Berlin
Berlin, 13353
Medizinische Univeritätsklinik Ruhr-Universität Bochum
Bochum, 44892
Klinikum Braunschweig
Braunschweig, 38114
Universitätsklinikum Essen, Innere Klinik (Tumorforschung)
Essen, 45122
Krankenhaus Nordwest, Klinik für Onkologie und Hämatologie
Frankfurt, 60488
Universitätsklinikum Halle
Halle, 06120
Universitäres Cancer Center Universitätsklinikum Eppendorf
Hamburg, 20246
Onkologische Schwerpunktpraxis Eppendorf
Hamburg, 20249
Universitätsklinikum Heidelberg, NCT
Heidelberg, 69120
Universitätsklinikum Leipzig
Leipzig, 04103
Universitätsmedizin der Johannes-Gutenberg Universität
Mainz, 55101
Klinikum rechts der Isar
München, 81675
Universitätsklinikum Ulm
Ulm, 89081
Bulgaria3 sites
Oncology Dispensary "Dr. Marko Markov"
Varna, 9002
MHAT "St.Marina"
Varna, 9010
Complex Oncology Center
Veliko Tarnovo, 5000
Latvia3 sites
Piejuras Hospital
Liepāja
Paula Stradina Clinical University Hospital
Riga, 1002
Riga East Clinical Research
Riga, 1038
About this study
Official title: International, Multicenter, Open-label, Phase II Study to Investigate the Efficacy and Safety of Multiple Doses of IMAB362 in Patients With Advanced Adenocarcinoma of the Stomach or the Lower Esophagus
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.
- Conditions
- Solid Tumors
- Being tested
- IMAB362
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMAB362Drug
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
| Study group | Role | What they receive |
|---|---|---|
| IMAB362 | Experimental | Two different doses (antibody / body surface area) of IMAB362 will be administered sequentially. Receives: Drug: IMAB362 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of remission (CR, PR) according to RECIST Criteria
Measured: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
Secondary outcomes (3)
Number of Participants with adverse events as a measure of safety and tolerability
Measured: 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
Measured: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
Progression-free-survival time (PFS)
The time from start of the first infusion to date of first observed disease progression or death due to progression (whichever is first)
Measured: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study start3 Sep 2010
- Primary completion13 Aug 2015
- Study completion13 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganymed Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Schuler, Prof. Dr. med., Principal investigator, Innere Klinik Universitätsklinikum Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197885
- Sponsor's protocol ID
- GM-IMAB-001-02
- Other IDs
- 2009-017365-36, 2009
- Status last verified
- Jun 2025
- First submitted
- 6 Sep 2010
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Tureci O, Sahin U, Schulze-Bergkamen H, Zvirbule Z, Lordick F, Koeberle D, Thuss-Patience P, Ettrich T, Arnold D, Bassermann F, Al-Batran SE, Wiechen K, Dhaene K, Maurus D, Gold M, Huber C, Krivoshik A, Arozullah A, Park JW, Schuler M. A multicentre, phase IIa study of zolbetuximab as a single agent in patients with recurrent or refractory advanced adenocarcinoma of the stomach or lower oesophagus: the MONO study. Ann Oncol. 2019 Sep 1;30(9):1487-1495. doi: 10.1093/annonc/mdz199.
PubMed 31240302
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter, Open-label, Phase II Study to Investigate the Efficacy and Safety of Multiple Doses of IMAB362 in Patients With Advanced Adenocarcinoma of the Stomach or the Lower Esophagus
- ClinicalTrials.gov ID
- NCT01197885
- Acronym / sponsor ID
- GM-IMAB-001-02
- Conditions
- Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ganymed Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2010 (actual)
- Primary completion
- 13 Aug 2015 (actual)
- Study completion
- 13 Aug 2015 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMAB362 | Experimental | Drug: IMAB362Two different doses (antibody / body surface area) of IMAB362 will be administered sequentially. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMAB362Cohort 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 | Drug | IMAB362 |
Primary outcome
Rate of remission (CR, PR) according to RECIST Criteria
Time frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
3 secondary outcomes
Number of Participants with adverse events as a measure of safety and tolerability
Time frame: 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
Time frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
Progression-free-survival time (PFS)
Time frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Derived from this study: PubMed 31240302Tureci O, Sahin U, Schulze-Bergkamen H, Zvirbule Z, Lordick F, Koeberle D, Thuss-Patience P, Ettrich T, Arnold D, Bassermann F, Al-Batran SE, Wiechen K, Dhaene K, Maurus D, Gold M, Huber C, Krivoshik A, Arozullah A, Park JW, Schuler M. A multicentre, phase IIa study of zolbetuximab as a single agent in patients with recurrent or refractory advanced adenocarcinoma of the stomach or lower oesophagus: the MONO study. Ann Oncol. 2019 Sep 1;30(9):1487-1495. doi: 10.1093/annonc/mdz199.
- Link to results and other applicable study documents on the Astellas Clinical Trials websiteLink provided by the sponsor.
- Link to plain language summary of the study on the Trial Results Summaries websiteLink provided by the sponsor.
- Updated Vivli WorksheetLink provided by the sponsor.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Schuler, Prof. Dr. med. principal investigator
Innere Klinik Universitätsklinikum Essen
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMAB362 in people with Solid Tumors, run by Ganymed Pharmaceuticals GmbH at 21 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany, Bulgaria, Latvia, Lithuania, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of remission (CR, PR) according to RECIST Criteria (time frame: All patients will be evaluated in 8-12 weeks intervals until 6 months after last infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01197885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.