Gastric CancerPhase 2NCT00464893
Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection
A Phase 2 study testing Catumaxomab in people with Gastric Cancer and Gastric Adenocarcinoma, run by Neovii Biotech at 4 sites in 4 countries.
Trial summary
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after curative tumor resection subsequent to a neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastric Adenocarcinoma
- What is being tested?
- Catumaxomab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Apr 2007to Apr 2013
- 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
- signed and dated informed consent
- male or female patient at an age of 18 years or older
- patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
- TNM-staging at screening of T3/T4, N+/-, M0 or T2, N+, M0
- indication and eligibility for a neoadjuvant chemotherapeutic regimen featuring three cycles of ECX with 21 days per cycle
- intended curative gastrectomy
- Karnofsky index > 70
Who cannot join
- Exposure to prior cancer therapy or planned adjuvant chemo- or radiotherapy of the current gastric cancer
- prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry
- previous use of non-humanized monoclonal mouse or rat antibodies
- treatment with another investigational product during this study or during the last 30 days prior to study start
- presence of distant metastases
- presence of constant immunosuppressive therapy
Show all 10Show fewer
- history of pancreas resection (also partial) or thoracotomy
- presence of any acute or chronic systemic infection
- patient with a bowel obstruction within the last 30 days
- known contraindications to any of the planned ECX chemotherapeutics
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Multicenter, Open-label Phase II Study to Evaluate the Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) in Patients With Gastric Adenocarcinoma After Neoadjuvant Chemotherapy and Intended Curative Resection
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after curative tumor resection subsequent to a neoadjuvant chemotherapy.
Read the detailed description
An open-label, multi-center phase II study in surgically resectable patients after neoadjuvant ECX-chemotherapy, with confirmed diagnosis of gastric adenocarcinoma and with a high risk of disseminated tumor cells due to serosal infiltration or positive lymph nodes after curative gastrectomy.
Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus and of four postoperative ascending doses (10-20-50-150 µg)which will be administered as an i.p.-infusion using an installed abdominal i.p.-port on the postoperative days 7, 10, 13 and 16.
Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.
- Conditions
- Gastric Cancer, Gastric Adenocarcinoma
- Being tested
- Catumaxomab
- Keywords
- gastric cancer, catumaxomab, neoadjuvant chemotherapy, phase II, interoperative, trifunctional antibody
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CatumaxomabDrug
Also called Removab
10 µg intraoperative and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
catumaxomabDrug
Also called Removab
10 µg intraoperatively and 4 ascending doses: 10, 20, 50 and 150 µg
| Study group | Role | What they receive |
|---|---|---|
| catumaxomab arm | Active comparator | Patients will get first the chemotherapeutic regimen (Epirubicin, Cisplatin and Capecitabine or 5-Fluorouracil) consisting of three 21-day cycles, starting on the weeks 1, 4 and 7. Four weeks after CTx the D2 surgery will take place. Treatment with catumaxomab will consist of an initial dose of 10µg given intraoperatively as in intraperitoneal bolus and of four postoperative ascending doses. Receives: Drug: Catumaxomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of all specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least the first 3 doses of catumaxomab
Measured: 30 days after last catumaxomab administration
Secondary outcomes (5)
frequency, relationship and seriousness of adverse events
Measured: 30 days after last catumaxomab administration
surgical resection rate
Measured: after surgery
chemotherapeutic response rate
Measured: after neoadjuvant CTx
overall survival at 3, 6, 9, 12 and 24 month after EOT, defined as the time from study enrolment until death
Measured: 2 years
disease-free survival at 3, 6, 9, 12 18 and 24 months after EOT, defined as the time from study enrolment to the point of diagnosis of recurrent disease or death, whichever occurred first
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2009
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neovii Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carsten Bokemeyer, Prof MD, Principal investigator, University Clinic of Hamburg-Eppendorf; 20246 Hamburg / Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464893
- Sponsor's protocol ID
- IP-CAT-GC-03
- Other IDs
- EudraCT-Nr.:2006-002727-16
- Status last verified
- Dec 2013
- First submitted
- 23 Apr 2007
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heiss MM, Strohlein MA, Jager M, Kimmig R, Burges A, Schoberth A, Jauch KW, Schildberg FW, Lindhofer H. Immunotherapy of malignant ascites with trifunctional antibodies. Int J Cancer. 2005 Nov 10;117(3):435-43. doi: 10.1002/ijc.21165.
PubMed 15906359Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.
PubMed 11588051Riesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7. doi: 10.1177/002215540104900711.
PubMed 11410615Zeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6. doi: 10.1054/bjoc.2000.1237.
PubMed 10901380Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.
PubMed 10415020
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label Phase II Study to Evaluate the Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) in Patients With Gastric Adenocarcinoma After Neoadjuvant Chemotherapy and Intended Curative Resection
- ClinicalTrials.gov ID
- NCT00464893
- Acronym / sponsor ID
- IP-CAT-GC-03
- Conditions
- Gastric Cancer, Gastric Adenocarcinoma
- Keywords
- gastric cancer, catumaxomab, neoadjuvant chemotherapy, phase II, interoperative, trifunctional antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Neovii BiotechIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Apr 2007 (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.
Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after curative tumor resection subsequent to a neoadjuvant chemotherapy.
Detailed description
An open-label, multi-center phase II study in surgically resectable patients after neoadjuvant ECX-chemotherapy, with confirmed diagnosis of gastric adenocarcinoma and with a high risk of disseminated tumor cells due to serosal infiltration or positive lymph nodes after curative gastrectomy.
Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus and of four postoperative ascending doses (10-20-50-150 µg)which will be administered as an i.p.-infusion using an installed abdominal i.p.-port on the postoperative days 7, 10, 13 and 16.
Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| catumaxomab arm | Active comparator | Drug: CatumaxomabPatients will get first the chemotherapeutic regimen (Epirubicin, Cisplatin and Capecitabine or 5-Fluorouracil) consisting of three 21-day cycles, starting on the weeks 1, 4 and 7. Four weeks after CTx the D2 surgery will take place. Treatment with catumaxomab will consist of an initial dose of 10µg given intraoperatively as in intraperitoneal bolus and of four postoperative ascending doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- signed and dated informed consent
- male or female patient at an age of 18 years or older
- patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
- TNM-staging at screening of T3/T4, N+/-, M0 or T2, N+, M0
- indication and eligibility for a neoadjuvant chemotherapeutic regimen featuring three cycles of ECX with 21 days per cycle
Key exclusion criteria (10 listed)
- Exposure to prior cancer therapy or planned adjuvant chemo- or radiotherapy of the current gastric cancer
- prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry
- previous use of non-humanized monoclonal mouse or rat antibodies
- treatment with another investigational product during this study or during the last 30 days prior to study start
- presence of distant metastases
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 |
|---|---|---|
| CatumaxomabAlso: Removab10 µg intraoperative and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16 | Drug | catumaxomab arm |
| catumaxomabAlso: Removab10 µg intraoperatively and 4 ascending doses: 10, 20, 50 and 150 µg | Drug | catumaxomab arm |
Primary outcome
rate of all specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least the first 3 doses of catumaxomab
Time frame: 30 days after last catumaxomab administration
5 secondary outcomes
frequency, relationship and seriousness of adverse events
Time frame: 30 days after last catumaxomab administration
surgical resection rate
Time frame: after surgery
chemotherapeutic response rate
Time frame: after neoadjuvant CTx
overall survival at 3, 6, 9, 12 and 24 month after EOT, defined as the time from study enrolment until death
Time frame: 2 years
disease-free survival at 3, 6, 9, 12 18 and 24 months after EOT, defined as the time from study enrolment to the point of diagnosis of recurrent disease or death, whichever occurred first
Time frame: 2 years
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 4 Dec 2013.
- Background: PubMed 15906359Heiss MM, Strohlein MA, Jager M, Kimmig R, Burges A, Schoberth A, Jauch KW, Schildberg FW, Lindhofer H. Immunotherapy of malignant ascites with trifunctional antibodies. Int J Cancer. 2005 Nov 10;117(3):435-43. doi: 10.1002/ijc.21165.
- Background: PubMed 11588051Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.
- Background: PubMed 11410615Riesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7. doi: 10.1177/002215540104900711.
- Background: PubMed 10901380Zeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6. doi: 10.1054/bjoc.2000.1237.
- Background: PubMed 10415020Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.
Related trials for Gastric Cancer
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
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Carsten Bokemeyer, Prof MD principal investigator
University Clinic of Hamburg-Eppendorf; 20246 Hamburg / Germany
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Catumaxomab in people with Gastric Cancer and Gastric Adenocarcinoma, run by Neovii Biotech at 4 sites in 4 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 7 inclusion and 10 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 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Germany, Spain, United Kingdom. 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 all specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least the first 3 doses of catumaxomab (time frame: 30 days after last catumaxomab administration). 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 NCT00464893, which also lists 5 linked publications.
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 4 Dec 2013.