Solid TumorsPhase 1MT110-101NCT00635596
Phase I Study of MT110 in Lung Cancer (Adenocarcinoma and Small Cell), Gastric Cancer or Adenocarcinoma of the Gastro-Esophageal Junction, Colorectal Cancer, Breast Cancer, Hormone-Refractory Prostate Cancer, and Ovarian Cancer
A Phase 1 study testing MT110 in people with Solid Tumors, run by Amgen Research (Munich) GmbH at 4 sites in Germany.
Trial summary
This phase I dose escalation study is intended to define the safety, tolerability and maximal tolerable dose (MTD) of MT110 in patients with advanced solid tumors. 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?
- MT110
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 4 sitesGermany
- Study dates
- Mar 2008to Jan 2015
- 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
- Locally advanced, recurrent or metastatic solid tumors known to widely express EpCAM and proven histology of the following entities:
- Adenocarcinoma of the lung
- Small cell lung cancer (SCLC)
- Gastric cancer or adenocarcinoma of gastro-esophageal junction
- Colorectal cancer (CRC)
- Hormone-refractory prostate cancer (HRPC)
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- Breast cancer
- Ovarian cancer
- Patients must not be amenable to curative therapy. Patients should have exhausted or declined standard therapeutic options and previous therapies should have included at least one course of chemotherapy.
- Non-measurable disease or at least one measurable tumor lesion as per RECIST criteria
- Age >/= 18 years
- ECOG performance status </= 2
- Life expectancy of at least 3 months
- Must have recovered from the acute reversible effects of previous anti-cancer chemotherapy, endocrine therapy, immunotherapy, radiotherapy or surgery.
- This generally means at least 4 weeks since major surgery, radical radiotherapy or myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin C).
- At least 4-5 half-lives (t1/2) must have elapsed since treatment with an investigational agent.
- At least 4 weeks since any hormonal therapy (except LHRH agonists for patients with HRPC) prior to initiating MT110 treatment.
- Ability to understand the patient information and informed consent form
- Signed and dated written informed consent
Who cannot join
- Evidence of central nervous system (CNS) metastases on baseline computer tomography (CT) or magnetic resonance imaging (MRI) scan (mandatory for all patients), current or past relevant history of other CNS pathology (except migraine, headache and minor incidental findings in the MRI without any clinical manifestation within the last five years). All minor incidental findings should be discussed with the Sponsor's Medical Monitor).
- Neutrophil count < 1,500/mm3 (= 1.5 x 10^9/l)
- Platelet count < 100,000/mm3 (= 100 x 10^9/l)
- White blood cells (WBC) < 3 x10^9/l
- Hemoglobin < 9.0 g/dl
- Abnormal renal or hepatic function as defined below:
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- Alkaline phosphatase (AP)>/= 2.5 x upper limit of normal (ULN) and/or aspartate aminotransferase (AST, SGOT), alanin aminotransferase (ALT, SGPT) >/= 2.0 x ULN or AP, AST and/or ALT >/= 3 x ULN in case of liver metastases; γ-glutamyl transpeptidase (GGT) >/= 5.0 x ULN
- Total bilirubin >/= 1.5 x ULN
- Creatinine clearance < 50 ml/min calculated by the Cockroft-Gault formula or MDRD (modification of diet in renal disease)
- Lipase/amylase > 1.5 x ULN
- D-dimer >/= 10 x ULN
- Antithrombin activity < 70%
- International normalized ratio (INR) > ULN
- Partial thromboplastin time (PTT) > ULN
- Oxygen (O2) saturation of < 92% (under room air condition)
- Any concurrent anti-neoplastic therapy with the exception of radiotherapy for palliation of symptoms after agreement by the Sponsor's Medical Monitor. No radiation is allowed for defined measurable lesions according to RECIST. Patients with HRPC who have received LHRH-agonist therapy for >1 month, should continue agonist therapy.
- Any concurrent disease, medical or social condition that could affect compliance with the protocol or interpretation of results as judged by the investigator. In particular, patients with the following conditions are not allowed to enter the study:
- Autoimmune and inflammatory diseases including vasculitis, rheumatoid arthritis, systemic lupus erythematosus (SLE), multiple sclerosis and similar conditions
- Active infection or known bacteremia
- Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus
- Severe dyspnea or pulmonary dysfunction or need for continuous supportive oxygen inhalation
- Insufficient cardiac function defined as NYHA (New York Heart Association) Grade 3 or 4
- History of acute or chronic pancreatitis
- Chronic systemic corticosteroid therapy longer than 2 months or any other immunosuppressive therapies or stem-cell transplantation.
- Presence of human anti-murine antibodies (HAMA) or known hypersensitivity to immunoglobulins or to other ingredients of the infusion solution.
- Pregnant, nursing women or women of childbearing potential who are not willing to use effective forms of contraception during participation in the study and at least three months thereafter.
- Male patients with partners of child-bearing potential who are not willing to use effective contraception during the trial and for at least three months thereafter, unless surgically sterile.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
University Hospital Freiburg Gynecological Clinic
Freiburg im Breisgau, Baden-Wurttemberg, 79106
University Hospital Hamburg-Eppendorf
Hamburg, 20246
Hospital Kassel
Kassel, 34125
University Hospital Würzburg
Würzburg, 97080
About this study
Official title: An Open-label, Multi-center Dose Escalation Phase I Study to Investigate the Safety and Tolerability of a Continuous Infusion of the Bispecific T-cell Engager (BiTE) MT110 in Locally Advanced, Recurrent or Metastatic Solid Tumors Which Commonly Express EpCAM and Are Not Amenable to Curative Treatment
This phase I dose escalation study is intended to define the safety, tolerability and maximal tolerable dose (MTD) of MT110 in patients with advanced solid tumors.
Read the detailed description
MT110 is a bispecific (anti-EpCAM x anti-CD3) T-cell engager (BiTE) designed to link EpCAM (epithelial cell adhesion molecule) expressing cells and T-cells resulting in T-cell activation and a cytotoxic T-cell response against EpCAM+ cells. In vitro and ex-vivo data indicate that EpCAM+ tumor cell lines are sensitive to MT110 mediated cytotoxicity. Furthermore, data from in-vivo experiments with both MT110 and a mouse surrogate molecule (muS110) have confirmed the activity of these molecules in inhibiting the formation of metastases but also against established tumors. In vitro and ex-vivo data suggest that a prolonged presence of the drug in target tissues may result in significant T-cell recruitment, activation and expansion to/in target tissues, potentially resulting in substantial anti-tumor activity in man.
- Conditions
- Solid Tumors
- Being tested
- MT110
- Keywords
- MT110, solid tumors, phase I, BiTE, bispecific T-cell engager
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT110Biological
Also called bispecific T-cell engager (BiTE)
MT110 treatment as continuous intravenous infusion over at least 28 days with increasing doses
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Not described Receives: Biological: MT110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall frequency and intensity of adverse events (AEs) (clinical symptoms, laboratory abnormalities, serious adverse events [SAEs] and dose-limiting toxicities)
Measured: one or more treatment cycles
Secondary outcomes (1)
Pharmacokinetics of MT110; T-cell counts, kinetics, and activation status; Serum cytokine concentrations; Immunogenicity; Anti-tumor activity; Other progressive disease (PD) parameters
Measured: one or more treatment cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen Research (Munich) GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Walter Fiedler, MD, Prof., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635596
- Sponsor's protocol ID
- MT110-101
- Other IDs
- EUDRACT No: 2007-004437-42
- Acronym
- MT110-101
- Status last verified
- Jan 2015
- First submitted
- 7 Mar 2008
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Dose Escalation Phase I Study to Investigate the Safety and Tolerability of a Continuous Infusion of the Bispecific T-cell Engager (BiTE) MT110 in Locally Advanced, Recurrent or Metastatic Solid Tumors Which Commonly Express EpCAM and Are Not Amenable to Curative Treatment
- ClinicalTrials.gov ID
- NCT00635596
- Acronym / sponsor ID
- MT110-101 / MT110-101
- Conditions
- Solid Tumors
- Keywords
- MT110, solid tumors, phase I, BiTE, bispecific T-cell engager
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Amgen Research (Munich) GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 14 Mar 2008 (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.
This phase I dose escalation study is intended to define the safety, tolerability and maximal tolerable dose (MTD) of MT110 in patients with advanced solid tumors.
Detailed description
MT110 is a bispecific (anti-EpCAM x anti-CD3) T-cell engager (BiTE) designed to link EpCAM (epithelial cell adhesion molecule) expressing cells and T-cells resulting in T-cell activation and a cytotoxic T-cell response against EpCAM+ cells. In vitro and ex-vivo data indicate that EpCAM+ tumor cell lines are sensitive to MT110 mediated cytotoxicity. Furthermore, data from in-vivo experiments with both MT110 and a mouse surrogate molecule (muS110) have confirmed the activity of these molecules in inhibiting the formation of metastases but also against established tumors. In vitro and ex-vivo data suggest that a prolonged presence of the drug in target tissues may result in significant T-cell recruitment, activation and expansion to/in target tissues, potentially resulting in substantial anti-tumor activity in man.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Biological: MT110 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Locally advanced, recurrent or metastatic solid tumors known to widely express EpCAM and proven histology of the following entities:
- Patients must not be amenable to curative therapy. Patients should have exhausted or declined standard therapeutic options and previous therapies should have included at least one course of chemotherapy.
- Non-measurable disease or at least one measurable tumor lesion as per RECIST criteria
- Age >/= 18 years
- ECOG performance status </= 2
Key exclusion criteria (27 listed)
- Evidence of central nervous system (CNS) metastases on baseline computer tomography (CT) or magnetic resonance imaging (MRI) scan (mandatory for all patients), current or past relevant history of other CNS pathology (except migraine, headache and minor incidental findings in the MRI without any clinical manifestation within the last five years). All minor incidental findings should be discussed with the Sponsor's Medical Monitor).
- Neutrophil count < 1,500/mm3 (= 1.5 x 10^9/l)
- Platelet count < 100,000/mm3 (= 100 x 10^9/l)
- White blood cells (WBC) < 3 x10^9/l
- Hemoglobin < 9.0 g/dl
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 |
|---|---|---|
| MT110Also: bispecific T-cell engager (BiTE)MT110 treatment as continuous intravenous infusion over at least 28 days with increasing doses | Biological | I |
Primary outcome
Overall frequency and intensity of adverse events (AEs) (clinical symptoms, laboratory abnormalities, serious adverse events [SAEs] and dose-limiting toxicities)
Time frame: one or more treatment cycles
1 secondary outcome
Pharmacokinetics of MT110; T-cell counts, kinetics, and activation status; Serum cytokine concentrations; Immunogenicity; Anti-tumor activity; Other progressive disease (PD) parameters
Time frame: one or more treatment cycles
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 Jan 2015.
Related trials for Solid Tumors
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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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.
Walter Fiedler, MD, Prof. principal investigator
Universitätsklinikum Hamburg-Eppendorf
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT110 in people with Solid Tumors, run by Amgen Research (Munich) GmbH at 4 sites in Germany.
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 19 inclusion and 27 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 Jan 2015. 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 Germany. 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?
Overall frequency and intensity of adverse events (AEs) (clinical symptoms, laboratory abnormalities, serious adverse events [SAEs] and dose-limiting toxicities) (time frame: one or more treatment cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2015.