Solid TumorsPhase 1NCT00909025
Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer
A Phase 1 study testing Claudiximab in people with Solid Tumors, run by Ganymed Pharmaceuticals GmbH at 6 sites in 2 countries.
Trial summary
Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and… 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?
- Claudiximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 31 May 2009to 31 May 2010
- Phase
- Phase 1
- 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 gastroesophageal cancer (adenocarcinoma) proven by histology
- CLDN18.2 expression confirmed by immunohistochemistry
- Prior standard chemotherapy containing a fluoropyrimidine, a platinum compound and/or epirubicine, and - if clinically appropriate - docetaxel
- At least 1 measurable site of the disease according RECIST criteria (CT-scans or MRT not older than 6 weeks before study entry)
- Age ≥ 18 years
- ECOG performance status (PS) 0-1 or Karnofsky Index 70-100%
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- Life expectancy > 3 months
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dl
- INR < 1.5
- 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
Who cannot join
- Pregnancy or breastfeeding
- Prior allergic reaction or intolerance to a monoclonal antibody
- Prior inclusion in the present study
- Less than 3 weeks since prior anti-tumor or radiation therapy
- Other investigational agents or devices concurrently or within 4 weeks prior to this study
- Other concurrent anticancer therapies
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- History of positive test for human immunodeficiency virus (HIV) antibody
- Known Hepatitis.
- Uncontrolled or severe illness.
- Concurrent administration of anticoagulation agents with vitamin K antagonists
- Concurrent administration of therapeutic doses of heparin (prophylactic doses are acceptable)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany4 sites
Universitätsklinikum Essen, Innere Klinik (Tumorforschung)
Essen, 45122
Universität Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, 69120
Johannes Gutenberg Universität, 1.Med Klinik und Poliklinik
Mainz, 55131
Klinikum Rechts-der-Isar, III.Medizinische Klinik und Poliklinik
München, 81674
Latvia2 sites
Piejuras Hospital
Liepāja, 3401
Pauls Stradins University
Riga, 1002
About this study
Official title: Clinical First-in-human Single-dose Escalation Study Evaluating the Safety and Tolerability of Claudiximab (iMAB-362) in Hospitalized Patients With Advanced Gastroesophageal Cancer. A Multi-center, Phase I, Open-label, i.v. Infusion Study
Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase I study is to establish safety, toxicity and maximal tolerable dose of a single infusion of claudiximab in patients suffering from relapsing, advanced gastroesophageal and gastric adenocarcinoma
- Conditions
- Solid Tumors
- Being tested
- Claudiximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClaudiximabDrug
Patients receive Claudiximab as intravenous infusion over 2 hours on day 1. Cohorts of 3-6 patients receive escalating doses of Claudiximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no dose-limiting toxicity (DLT) is diagnosed in 3 patients or no more than 1 out of 6 patients exhibits a DLT.
After completion of study treatment, patients are followed for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Claudiximab | Experimental | Not described Receives: Drug: Claudiximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of maximum tolerated dose of claudiximab (Phase I: toxicities as assessed by NCI CTCAE version 3.0)
Measured: Four weeks
Secondary outcomes (5)
Determination of the safety profile
Measured: Four weeks
Pharmacokinetic evaluation
Measured: Four weeks
Overall tumor response as assessed by RECIST
Measured: Four weeks
Evaluation of immunogenicity
Measured: Four weeks
Determination of antitumoral efficacy
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study start31 May 2009
- Primary completion31 May 2010
- Study completion31 May 2010
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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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 (Tumorforschung) Universitätsklinikum Essen Hufelandstr. 55 45122 Essen, GERMANY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909025
- Sponsor's protocol ID
- GM-IMAB-001
- Status last verified
- Nov 2024
- First submitted
- 18 May 2009
- Last updated
- 21 Nov 2024
- 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
Sahin U, Schuler M, Richly H, Bauer S, Krilova A, Dechow T, Jerling M, Utsch M, Rohde C, Dhaene K, Huber C, Tureci O. A phase I dose-escalation study of IMAB362 (Zolbetuximab) in patients with advanced gastric and gastro-oesophageal junction cancer. Eur J Cancer. 2018 Sep;100:17-26. doi: 10.1016/j.ejca.2018.05.007. Epub 2018 Jun 21.
PubMed 29936063
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical First-in-human Single-dose Escalation Study Evaluating the Safety and Tolerability of Claudiximab (iMAB-362) in Hospitalized Patients With Advanced Gastroesophageal Cancer. A Multi-center, Phase I, Open-label, i.v. Infusion Study
- ClinicalTrials.gov ID
- NCT00909025
- Acronym / sponsor ID
- GM-IMAB-001
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ganymed Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- 31 May 2009 (actual)
- Primary completion
- 31 May 2010 (actual)
- Study completion
- 31 May 2010 (actual)
- First posted
- 27 May 2009 (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.
Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase I study is to establish safety, toxicity and maximal tolerable dose of a single infusion of claudiximab in patients suffering from relapsing, advanced gastroesophageal and gastric adenocarcinoma
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Claudiximab | Experimental | Drug: Claudiximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Metastatic, refractory or recurrent disease of advanced gastroesophageal cancer (adenocarcinoma) proven by histology
- CLDN18.2 expression confirmed by immunohistochemistry
- Prior standard chemotherapy containing a fluoropyrimidine, a platinum compound and/or epirubicine, and - if clinically appropriate - docetaxel
- At least 1 measurable site of the disease according RECIST criteria (CT-scans or MRT not older than 6 weeks before study entry)
- Age ≥ 18 years
Key exclusion criteria (11 listed)
- Pregnancy or breastfeeding
- Prior allergic reaction or intolerance to a monoclonal antibody
- Prior inclusion in the present study
- Less than 3 weeks since prior anti-tumor or radiation therapy
- Other investigational agents or devices concurrently or within 4 weeks prior to this study
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 |
|---|---|---|
| ClaudiximabPatients receive Claudiximab as intravenous infusion over 2 hours on day 1. Cohorts of 3-6 patients receive escalating doses of Claudiximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no dose-limiting toxicity (DLT) is diagnosed in 3 patients or no more than 1 out of 6 patients exhibits a DLT. After completion of study treatment, patients are followed for 4 weeks. | Drug | Claudiximab |
Primary outcome
Determination of maximum tolerated dose of claudiximab (Phase I: toxicities as assessed by NCI CTCAE version 3.0)
Time frame: Four weeks
5 secondary outcomes
Determination of the safety profile
Time frame: Four weeks
Pharmacokinetic evaluation
Time frame: Four weeks
Overall tumor response as assessed by RECIST
Time frame: Four weeks
Evaluation of immunogenicity
Time frame: Four weeks
Determination of antitumoral efficacy
Time frame: Four weeks
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 21 Nov 2024.
- Derived from this study: PubMed 29936063Sahin U, Schuler M, Richly H, Bauer S, Krilova A, Dechow T, Jerling M, Utsch M, Rohde C, Dhaene K, Huber C, Tureci O. A phase I dose-escalation study of IMAB362 (Zolbetuximab) in patients with advanced gastric and gastro-oesophageal junction cancer. Eur J Cancer. 2018 Sep;100:17-26. doi: 10.1016/j.ejca.2018.05.007. Epub 2018 Jun 21.
- 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.
- 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/.
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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 (Tumorforschung) Universitätsklinikum Essen Hufelandstr. 55 45122 Essen, GERMANY
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Claudiximab in people with Solid Tumors, run by Ganymed Pharmaceuticals GmbH at 6 sites in 2 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 13 inclusion and 11 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Latvia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Determination of maximum tolerated dose of claudiximab (Phase I: toxicities as assessed by NCI CTCAE version 3.0) (time frame: Four weeks). 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 NCT00909025, 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 21 Nov 2024.