Solid TumorsPhase 1NCT01222637
CetuGEX™: Phase 1 Study in Cancer Patients
A Phase 1 study testing CetuGEX™ in people with Solid Tumors, run by Glycotope GmbH at 5 sites in 3 countries.
Trial summary
This was a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of CetuGEX™ after intravenous administration in patients with EGFR positive, locally advanced and/or metastatic solid cancers. 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?
- CetuGEX™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Aug 2010to Oct 2013
- 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
- Male or female and age ≥ 18 yrs
- Histologically confirmed EGFR positive locally advanced and/or metastatic solid organ tumour
- Measurable or non-measurable tumour
- Failure of standard therapy or non-availability of standard therapy (Patients must have received at least 1 line of chemotherapy and further standard therapy is not an option at study entry)
- All anti-tumour therapies must be completed 4 weeks before start of study treatment; treatment with Cetuximab must be completed at least 6 weeks prior to study start
- ECOG Performance Status ≤1 and estimated life expectancy of ≥ 3 months
Show all 14Show fewer
- Adequate organ function:
- Bone marrow function: hemoglobin ≥ 100 g/L; white blood cell count (WBC) ≥ 3.0 x 10^9/L; absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; platelet count ≥ 100 x 10^9/L
- Hepatic: aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤ 2.5 times upper limit of normal (ULN) (≤ 5 x ULN if hepatic metastases present); bilirubin ≤ 1.5 x ULN; alkaline phosphatase ≤ 5.0 x upper limit of normal (ULN)
- Renal: creatinine < 1.5 x ULN
- Patients of both genders with procreative potential must use effective contraception while enrolled in the study and for at least 4 weeks after the last study drug infusion
- Written informed consent must be obtained prior to conducting any study-specific procedures
- For Expansion Phase only:
- No prior treatment with Cetuximab allowed
Who cannot join
- Chemotherapy, radiation, other anti-cancer therapies including any investigational agents at the study enrolment within 4 weeks prior to study enrolment
- Concurrent anti-tumour therapy or concurrent immunotherapy
- Concurrent systemic steroids except topical (inhaled, topical, nasal) or replacement therapy for the last 28 days.
- Major surgery within 4 weeks prior entering the study and/or incomplete recovery from surgery or planned major surgery
- Primary or secondary immune deficiency
- Clinically active infections > CTCAE grade 2
Show all 14Show fewer
- Prior allergic reaction to a monoclonal antibody (e.g. Trastuzumab, Cetuximab or Bevacizumab).
- Active hepatitis B assessed by serology, hepatitis C by histology; human immunodeficiency virus (HIV) seropositivity
- Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for ≥ 3 years will be allowed to enter the study.
- Uncontrolled medical condition considered as high risk for the treatment with an investigational drug including unstable diabetes mellitus, vena-cava-syndrome, chronic symptomatic respiratory disease.
- Clinical signs of brain metastasis or leptomeningeal involvement
- Symptomatic congestive heart failure (New York Heart Association [NYHA] 3 or 4); unstable angina pectoris within 6 months prior to enrollment; significant cardiac arrhythmia, or history of stroke or transient ischemic attack within 1 year.
- Active drug abuse or chronic alcoholism
- Pregnancy or Breastfeeding
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Germany2 sites
Glycotope Investigational Site
Hamburg, D-20246
Glycotope Investigational Site
Heidelberg, D-69120
Italy2 sites
Glycotope Investigational Site
Milan, 20132
Glycotope Investigational Site
Milan, 20133
About this study
Official title: Dose-escalation, PK- and Safety Study With Single Agent CetuGEX™ in Patients With EGFR Positive Locally Advanced and/or Metastatic Cancer
This was a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of CetuGEX™ after intravenous administration in patients with EGFR positive, locally advanced and/or metastatic solid cancers. The effect of CetuGEX™ on the development of anti-drug antibodies and on tumour response was also evaluated.
Read the detailed description
Male or female patients ≥18 years of age with a histologically confirmed locally advanced and/or metastatic solid organ tumor. Patients enrolled in Germany were required to have a positive EGFR overexpression status. Patients must have experienced a failure or non-availability of standard therapy (had received at least one line of chemotherapy and further standard therapy was not an option at study entry). Open-label, non-randomized, inter-patient dose-escalation, multi-center study. Patients were to receive CetuGEX until disease progression or until intolerable toxicities occurred.
- Conditions
- Solid Tumors
- Being tested
- CetuGEX™
- Keywords
- advanced solid cancers, metastatic solid cancers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuGEX™Drug
Also called tomuzotuximab
| Study group | Role | What they receive |
|---|---|---|
| CetuGEX™, weekly | Experimental | application weekly Receives: Drug: CetuGEX™ |
| CetuGEX™ 2-weekly | Experimental | application biweekly Receives: Drug: CetuGEX™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAE) assessed with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
TEAE were coded by use of Medical Dictionary for Regulatory Activities (MedDRA) version 13.1
Measured: throughout the study until 28±2 days after last infusion
Incidence of clinically relevant abnormal clinical laboratory parameters
graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
Measured: from first infusion until 28±2 days following the last infusion
Dose-limiting toxicities (DLT)
DLTs were defined as drug-related:
- Hematological or non-hematological toxicity grade 3 (excl. rash) or 4 excluding inadequately treated nausea and vomiting;
- In case of skin reaction (rash) grade 4
Measured: from first infusion until 28±2 days following the last infusion
Changes of corrected QT interval (QTc) duration
by use of 12-lead electrocardiograms (ECG)
Measured: from first infusion until 28±2 days following the last infusion
To define the recommended phase II dose and regimen
Defining a recommended dose for a Phase II study was possible based on the available PK data in combination with the safety and activity data for CetuGEX™
Measured: from first infusion until 28±2 days following the last infusion
Secondary outcomes (10)
Anti-Tumor Activity: Confirmed Best Overall Response Rates
Assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Tumors were measured by computed tomography (CT) scan or magnetic resonance imaging (MRI)
Measured: From date of randomization until the date of first documented progression, assessed up to 60 months
Anti-Tumor Activity: Clinical Benefit Rates
Assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Tumors were measured by computed tomography (CT) scan or magnetic resonance imaging (MRI)
Measured: From date of randomization until the date of first documented progression, assessed up to 60 months
Eastern Cooperative Oncology Group (ECOG) Performance Status
The ECOG Scale of Performance Status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). The scale comprises six grades:
0 Fully active, able to carry on all pre-disease performance without restriction
- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
- Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
- Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
- Dead
Measured: From date of randomization until 28 days ± 2 days after the end of treatment
Pharmacokinetics (PK): Area under the serum concentration-time curve (AUC)
PK of CetuGEX™ after single and multiple administration
Measured: Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
Pharmacokinetics (PK): Maximum serum concentration (Cmax)
PK of CetuGEX™ after single and multiple administration
Measured: Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
Pharmacokinetics (PK): Time to maximum serum concentration (tmax)
PK of CetuGEX™ after single and multiple administration
Measured: Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
Pharmacokinetics (PK): Minimal serum concentration (Cmin)
PK of CetuGEX™ after single and multiple administration
Measured: Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
Pharmacokinetics (PK): Terminal elimination half-life (t1/2)
PK of CetuGEX™ after single and multiple administration
Measured: Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
Pharmacokinetics (PK): Clearance rate (CL)
PK of CetuGEX™ after single and multiple administration
Measured: Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
Pharmacokinetics (PK): Volume of distribution (Vz)
PK of CetuGEX™ after single and multiple administration
Measured: Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2012
- Study completionOct 2013
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycotope GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glycotope GmbH, Study director, Glycotope GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222637
- Sponsor's protocol ID
- GEXMab52101
- Status last verified
- May 2021
- First submitted
- 15 Oct 2010
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fiedler W, Cresta S, Schulze-Bergkamen H, De Dosso S, Weidmann J, Tessari A, Baumeister H, Danielczyk A, Dietrich B, Goletz S, Zurlo A, Salzberg M, Sessa C, Gianni L. Phase I study of tomuzotuximab, a glycoengineered therapeutic antibody against the epidermal growth factor receptor, in patients with advanced carcinomas. ESMO Open. 2018 Feb 1;3(2):e000303. doi: 10.1136/esmoopen-2017-000303. eCollection 2018.
PubMed 29464112
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-escalation, PK- and Safety Study With Single Agent CetuGEX™ in Patients With EGFR Positive Locally Advanced and/or Metastatic Cancer
- ClinicalTrials.gov ID
- NCT01222637
- Acronym / sponsor ID
- GEXMab52101
- Conditions
- Solid Tumors
- Keywords
- advanced solid cancers, metastatic solid cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Glycotope GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Oct 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.
This was a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of CetuGEX™ after intravenous administration in patients with EGFR positive, locally advanced and/or metastatic solid cancers. The effect of CetuGEX™ on the development of anti-drug antibodies and on tumour response was also evaluated.
Detailed description
Male or female patients ≥18 years of age with a histologically confirmed locally advanced and/or metastatic solid organ tumor. Patients enrolled in Germany were required to have a positive EGFR overexpression status. Patients must have experienced a failure or non-availability of standard therapy (had received at least one line of chemotherapy and further standard therapy was not an option at study entry). Open-label, non-randomized, inter-patient dose-escalation, multi-center study. Patients were to receive CetuGEX until disease progression or until intolerable toxicities occurred.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CetuGEX™, weekly | Experimental | Drug: CetuGEX™application weekly |
| CetuGEX™ 2-weekly | Experimental | Drug: CetuGEX™application biweekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female and age ≥ 18 yrs
- Histologically confirmed EGFR positive locally advanced and/or metastatic solid organ tumour
- Measurable or non-measurable tumour
- Failure of standard therapy or non-availability of standard therapy (Patients must have received at least 1 line of chemotherapy and further standard therapy is not an option at study entry)
- All anti-tumour therapies must be completed 4 weeks before start of study treatment; treatment with Cetuximab must be completed at least 6 weeks prior to study start
Key exclusion criteria (14 listed)
- Chemotherapy, radiation, other anti-cancer therapies including any investigational agents at the study enrolment within 4 weeks prior to study enrolment
- Concurrent anti-tumour therapy or concurrent immunotherapy
- Concurrent systemic steroids except topical (inhaled, topical, nasal) or replacement therapy for the last 28 days.
- Major surgery within 4 weeks prior entering the study and/or incomplete recovery from surgery or planned major surgery
- Primary or secondary immune deficiency
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 |
|---|---|---|
| CetuGEX™Also: tomuzotuximab | Drug | CetuGEX™ 2-weekly, CetuGEX™, weekly |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAE) assessed with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
Time frame: throughout the study until 28±2 days after last infusion
TEAE were coded by use of Medical Dictionary for Regulatory Activities (MedDRA) version 13.1
Incidence of clinically relevant abnormal clinical laboratory parameters
Time frame: from first infusion until 28±2 days following the last infusion
graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
Dose-limiting toxicities (DLT)
Time frame: from first infusion until 28±2 days following the last infusion
DLTs were defined as drug-related: * Hematological or non-hematological toxicity grade 3 (excl. rash) or 4 excluding inadequately treated nausea and vomiting; * In case of skin reaction (rash) grade 4
Changes of corrected QT interval (QTc) duration
Time frame: from first infusion until 28±2 days following the last infusion
by use of 12-lead electrocardiograms (ECG)
To define the recommended phase II dose and regimen
Time frame: from first infusion until 28±2 days following the last infusion
Defining a recommended dose for a Phase II study was possible based on the available PK data in combination with the safety and activity data for CetuGEX™
10 secondary outcomes
Anti-Tumor Activity: Confirmed Best Overall Response Rates
Time frame: From date of randomization until the date of first documented progression, assessed up to 60 months
Anti-Tumor Activity: Clinical Benefit Rates
Time frame: From date of randomization until the date of first documented progression, assessed up to 60 months
Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: From date of randomization until 28 days ± 2 days after the end of treatment
Pharmacokinetics (PK): Area under the serum concentration-time curve (AUC)
Time frame: Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
Pharmacokinetics (PK): Maximum serum concentration (Cmax)
Time frame: Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
Pharmacokinetics (PK): Time to maximum serum concentration (tmax)
Time frame: Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
Pharmacokinetics (PK): Minimal serum concentration (Cmin)
Time frame: Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
Pharmacokinetics (PK): Terminal elimination half-life (t1/2)
Time frame: Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
Pharmacokinetics (PK): Clearance rate (CL)
Time frame: Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 weeks
Pharmacokinetics (PK): Volume of distribution (Vz)
Time frame: Prior to 1st infusion, end of 1st infusion, 4 hours after end, 72 and 168 hours after start of 1st infusion, then before and after each infusion up to 10 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 25 May 2021.
- Results publication: PubMed 29464112Fiedler W, Cresta S, Schulze-Bergkamen H, De Dosso S, Weidmann J, Tessari A, Baumeister H, Danielczyk A, Dietrich B, Goletz S, Zurlo A, Salzberg M, Sessa C, Gianni L. Phase I study of tomuzotuximab, a glycoengineered therapeutic antibody against the epidermal growth factor receptor, in patients with advanced carcinomas. ESMO Open. 2018 Feb 1;3(2):e000303. doi: 10.1136/esmoopen-2017-000303. eCollection 2018.
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.
Glycotope GmbH study director
Glycotope GmbH
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CetuGEX™ in people with Solid Tumors, run by Glycotope GmbH at 5 sites in 3 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 14 inclusion and 14 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 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Italy, 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 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?
Incidence of Treatment-Emergent Adverse Events (TEAE) assessed with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 (time frame: throughout the study until 28±2 days after last infusion). The study lists 5 primary outcomes in all. 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 NCT01222637, 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 25 May 2021.