Solid Tumor, AdultPhase 1GATTONCT03360734
Combination of Gatipotuzumab and Tomuzotuximab in Patients With Solid Tumors
A Phase 1 study testing First part: Gatipotuzumab and Tomuzotuximab; Second part: Gatipotuzumab and Tomuzotuximab or anti-EGFR antibody (Cetuximab, Panitumumab or Necitumumab) in people with Solid Tumor, Adult, run by Glycotope GmbH at 4 sites in 3 countries.
Trial summary
This was a single arm phase Ib study to evaluate the safety and efficacy of combined Tomuzotuximab and Gatipotuzumab therapy in patients with metastatic solid tumors expressing EGFR for whom no standard treatment is available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- First part: Gatipotuzumab and Tomuzotuximab; Second part: Gatipotuzumab and Tomuzotuximab or anti-EGFR antibody (Cetuximab, Panitumumab or Necitumumab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 2 Nov 2017to 29 Sep 2020
- 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 years
- Histologically confirmed locally advanced and/or metastatic solid organ tumor including but not limited to the following histology: Non-Small Cell Lung cancer (NSCLC), Gastrointestinal cancer (GI), Breast cancer (BC), Gynecological cancers (GYN). Date of histology should be not older than 18 months from the start of the screening procedures. Additionally 30 patients will be enrolled in 4 expansion cohorts: 1) refractory metastatic Colorectal cancer (mCRC) patients who have failed prior treatment with standard chemotherapeutics and both anti-VEGF and anti-EGFR antibodies; 2) patients with recurrent and/or metastatic Head and Neck cancers, who have failed prior treatment with a checkpoint inhibitor and at least one line of chemotherapy as appropriate depending on the histology and platinum-elegibility; salivary gland tumors can be enrolled in this cohort after failure of at least one line of chemotherapy; 3) refractory metastatic NonSmall Cell Lung cancer (NSCLC) patients who have failed all standard treatment options including chemotherapy, tyrosine kinase inhibitors and immunotherapy as appropriate depending on the histology and mutational status, 4) refractory metastatic Breast cancer (BC) patients who have failed all standard treatment options including chemotherapy, hormone therapy and anti-human epidermal growth factor receptor 2 [HER2] treatment as appropriate depending on the histology.
- Patients are required to have a positive EGFR IHC expression (≥25% of tumor cells) as assessed by local laboratory. This condition will not be required anymore in the additional 30 patients of the expansion cohorts
- Measurable disease according to RECIST 1.1. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have a short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines
- Failure of standard therapy or non-availability of standard therapy (patients must have received at least one line of chemotherapy and further standard therapy is not an option at study entry)
- Prior treatment with any anti-EGFR agent should be completed at least 4 months before start of treatment. This condition will no longer be required in the 30 additional patients of the expansion cohorts.
Show all 15Show fewer
- Toxicities, except for alopecia and Grade 2 neuropathy, should be not greater than Grade 1 before start of treatment according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE [v. 4.0])
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 and estimated life expectancy of ≥3 months
- Adequate organ function as evidenced by the following:
- Bone marrow function: hemoglobin ≥90 g/L; white blood cell (WBC) count ≥3.0 x 109/L; absolute neutrophil count (ANC) ≥1.0 x 109/L; platelet count ≥75 x 109/L
- Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (≤5 x ULN if hepatic metastases present); bilirubin ≤1.5 x ULN; alkaline phosphatase ≤5.0 x ULN
- Renal function: creatinine <1.5 x ULN
- Cardiologic function: LVEF fraction ≥ 50% assessed by radionuclide angiography (MUGA scan) or Echocardiography
- Patients of both genders with procreative potential must use effective contraception while enrolled in the study and for at least 6 months (for women) or 16 weeks (for men) after the last study drug infusion
- Written informed consent obtained prior to conducting any study specific procedures
Who cannot join
- First 20 patients: Known activating EGFR mutation. This exclusion criterion will no more apply for the 30 additional patients of the expansion cohorts.
- Involvement in the planning and/or conduct of the study (applies to both Glycotope staff and/or staff at the study site)
- Concurrent enrolment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study
- Patients institutionalized by official means or court order.
- Chemotherapy, radiation, or any other anti-cancer therapies, including any investigational agent, within 4 weeks prior start of study treatment
- Concurrent anti-tumor therapy or concurrent immunotherapy
Show all 30Show fewer
- Current or prior use of immunosuppressive medication within 28 days before the first dose of study drug. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Major surgery within 4 weeks prior to entering the study and/or incomplete recovery from surgery or planned major surgery
- Primary or secondary immune deficiency requiring treatment. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- Patients with celiac disease controlled by diet only
- Clinically active infections >Grade 2 according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE v. 4.0)
- Patients with known severe allergy or hypersensitivity to other human monoclonal antibodies or who experienced infusion related reactions or other severe toxicity that required permanent interruption of a prior antibody treatment.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- History of another primary malignancy except for: a. Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of IMP and of low potential risk for recurrence b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease c. Adequately treated carcinoma in situ without evidence of disease d. Localized prostate cancer
- Uncontrolled medical condition considered as high risk for treatment with an investigational drug including unstable diabetes mellitus, vena-cava-syndrome, or chronic symptomatic respiratory disease
- Clinical signs of brain metastasis or leptomeningeal involvement
- Symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV), unstable angina pectoris or MI within 6 months prior to enrollment, significant cardiac arrhythmia, history of stroke, or transient ischemic attack within 1 year
- History of seizures, encephalitis, or multiple sclerosis
- Active drug abuse or chronic alcoholism
- Pregnant or breastfeeding
- Known sensitivity to any component of the drugs used
- Contraindication to the premedication (H1 and/or H2 receptor antagonists and steroids) or commercial anti-EGFR used in this study
- Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Glycotope-contracted research facility
Berlin, 1xxxx
Glycotope-contracted research facility
Hamburg, 2xxxx
About this study
Official title: A Phase Ib Study to Evaluate the Safety, Tolerability and Efficacy of Gatipotuzumab and Tomuzotuximab Combination in Patients With EGFR-Positive Metastatic Solid Tumors
This was a single arm phase Ib study to evaluate the safety and efficacy of combined Tomuzotuximab and Gatipotuzumab therapy in patients with metastatic solid tumors expressing EGFR for whom no standard treatment is available. Patients who had relapsed following their most recent line of chemotherapy and who met all other entry criteria at Screening were enrolled to receive Tomuzotuximab and Gatipotuzumab in combination.
During the extension phase, instead of Tomuzotuximab a commercially avalaible anti-EGFR antibody, i.e. Cetuximab (including any approved biosimilar), Panitumumab, or Necitumumab could be given to patients with cancers for which their use is approved.
Read the detailed description
Tomuzotuximab (CetuGEX®) is an improved second-generation anti-epidermal growth factor receptor (EGFR) antibody that specifically binds to EGFR and acts as a competitive antagonist at the EGFR ligand binding site.
Gatipotuzumab (PankoMab-GEX®) is a novel glyco-engineered humanized monoclonal antibody, which recognizes the tumor-specific epitope of mucin-1 (TA-MUC1). Gatipotuzumab targets and binds TA-MUC1 epitopes on the surface of tumor cells, potentially activating the immune system to induce ADCC against TA-MUC1 expressing tumor cells.
Based on compelling preclinical evidence suggesting a complex interaction between EGFR and TA-MUC1 expressed on the tumor cell surface in driving carcinogenesis, this study assessed the tolerability, safety and preliminary activity of targeting EGFR and TA-MUC1 with glycoengineered antibodies.
After the safe treatment of 20 patients and the absence of dose-limiting toxicity (DLT), the combination of the two antibodies was considered safe and was started in the second week of treatment for the additional 30 patients to be enrolled in the extension cohort.
- Conditions
- Solid Tumor, Adult
- Being tested
- First part: Gatipotuzumab and Tomuzotuximab; Second part: Gatipotuzumab and Tomuzotuximab or anti-EGFR antibody (Cetuximab, Panitumumab or Necitumumab)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First part: Gatipotuzumab and Tomuzotuximab; Second part: Gatipotuzumab and Tomuzotuximab or anti-EGFR antibody (Cetuximab, Panitumumab or Necitumumab)Drug
Also called PankoMab-GEX (GAT) and CetuGEX (TOM)
Two monoclonal antibodies, Gatipotuzumab is anti-TAMUC1, Tomuzotuximab is anti-EGFR
| Study group | Role | What they receive |
|---|---|---|
| Combination | Experimental | First part: Combination of Gatipotuzumab (GAT) and Tomuzotuximab (TOM) Treatment: 5 weeks monotherapy with TOM (Day 1: 60mg, Day 2: 660mg, Week 2: 1200mg, Week 4: 1200mg). Then combination of 1200mg TOM with 1400mg of GAT every two weeks until disease progression, as long as patient does not meet any other discontinuation criterion such as unacceptable toxicity.
Second part: Combination of GAT and TOM or an approved anti-EGFR antibody, i.e. Cetuximab, Panitumumab, or Necitumumab Treatment: One week monotherapy with TOM (Week 1, Day 1: 60mg, Day 2: 660mg). Then 1200mg TOM in combination with 1400mg of GAT every two weeks until disease progression, as long as patient does not meet any other discontinuation criterion such as unacceptable toxicity or commercial anti-EGFR antibody (dosage according to local practices) in combination with 1400mg of GAT every two weeks until disease progression or until unacceptable toxicity Receives: Drug: First part: Gatipotuzumab and Tomuzotuximab; Second part: Gatipotuzumab and Tomuzotuximab or anti-EGFR antibody (Cetuximab, Panitumumab or Necitumumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence and Severity of adverse events (AEs) and IRRs
Incidence of adverse events (AEs) and IRRs
Measured: 12 months
Overall tolerability
Standard safety assessments in terms of laboratory evaluations, vital signs, electrocardiogram [ECG], and physical examinations
Measured: 12 months
Secondary outcomes (3)
Efficacy of the combined treatment: Objective response rate (ORR)
Objective response rate (ORR), Progression free Survival and Overall survival
Measured: 12 months
Immunogenicity of combined Treatment: incidence of anti-drug antibodies (ADAs)
incidence of anti-drug antibodies (ADAs)
Measured: 12 months
Pharmacokinetics (PK) of combined Treatment: Concentration
Concentration of Gatipotuzumab and Tomuzotuximab in blood and noncompartmental PK parameters
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start2 Nov 2017
- Primary completion4 May 2020
- Study completion29 Sep 2020
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 Tumor, AdultStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycotope GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastian Ochsenreither, Dr. med., Principal investigator, Charité Benjamin Franklin Comprehensive Cancer Center,Hindenburgdamm 30,12200/12203 Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360734
- Sponsor's protocol ID
- 5225101
- Other IDs
- 2017-001609-33, 2017
- Acronym
- GATTO
- Status last verified
- Jul 2021
- First submitted
- 20 Nov 2017
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ochsenreither S, Fiedler WM, Conte GD, Macchini M, Matos I, Habel B, Ahrens-Fath I, Raspagliesi F, Lorusso D, Keilholz U, Rolling C, Kebenko M, Klinghammer KF, Saavedra O, Baumeister H, Zurlo A, Garralda E. Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors. ESMO Open. 2022 Apr;7(2):100447. doi: 10.1016/j.esmoop.2022.100447. Epub 2022 Apr 6.
PubMed 35397434
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Evaluate the Safety, Tolerability and Efficacy of Gatipotuzumab and Tomuzotuximab Combination in Patients With EGFR-Positive Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT03360734
- Acronym / sponsor ID
- GATTO / 5225101
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Glycotope GmbHIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 4 Dec 2017 (actual)
- 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 single arm phase Ib study to evaluate the safety and efficacy of combined Tomuzotuximab and Gatipotuzumab therapy in patients with metastatic solid tumors expressing EGFR for whom no standard treatment is available. Patients who had relapsed following their most recent line of chemotherapy and who met all other entry criteria at Screening were enrolled to receive Tomuzotuximab and Gatipotuzumab in combination.
During the extension phase, instead of Tomuzotuximab a commercially avalaible anti-EGFR antibody, i.e. Cetuximab (including any approved biosimilar), Panitumumab, or Necitumumab could be given to patients with cancers for which their use is approved.
Detailed description
Tomuzotuximab (CetuGEX®) is an improved second-generation anti-epidermal growth factor receptor (EGFR) antibody that specifically binds to EGFR and acts as a competitive antagonist at the EGFR ligand binding site.
Gatipotuzumab (PankoMab-GEX®) is a novel glyco-engineered humanized monoclonal antibody, which recognizes the tumor-specific epitope of mucin-1 (TA-MUC1). Gatipotuzumab targets and binds TA-MUC1 epitopes on the surface of tumor cells, potentially activating the immune system to induce ADCC against TA-MUC1 expressing tumor cells.
Based on compelling preclinical evidence suggesting a complex interaction between EGFR and TA-MUC1 expressed on the tumor cell surface in driving carcinogenesis, this study assessed the tolerability, safety and preliminary activity of targeting EGFR and TA-MUC1 with glycoengineered antibodies.
After the safe treatment of 20 patients and the absence of dose-limiting toxicity (DLT), the combination of the two antibodies was considered safe and was started in the second week of treatment for the additional 30 patients to be enrolled in the extension cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination | Experimental | Drug: First part: Gatipotuzumab and Tomuzotuximab; Second part: Gatipotuzumab and Tomuzotuximab or anti-EGFR antibody (Cetuximab, Panitumumab or Necitumumab)First part: Combination of Gatipotuzumab (GAT) and Tomuzotuximab (TOM) Treatment: 5 weeks monotherapy with TOM (Day 1: 60mg, Day 2: 660mg, Week 2: 1200mg, Week 4: 1200mg). Then combination of 1200mg TOM with 1400mg of GAT every two weeks until disease progression, as long as patient does not meet any other discontinuation criterion such as unacceptable toxicity. Second part: Combination of GAT and TOM or an approved anti-EGFR antibody, i.e. Cetuximab, Panitumumab, or Necitumumab Treatment: One week monotherapy with TOM (Week 1, Day 1: 60mg, Day 2: 660mg). Then 1200mg TOM in combination with 1400mg of GAT every two weeks until disease progression, as long as patient does not meet any other discontinuation criterion such as unacceptable toxicity or commercial anti-EGFR antibody (dosage according to local practices) in combination with 1400mg of GAT every two weeks until disease progression or until unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female and age ≥18 years
- Histologically confirmed locally advanced and/or metastatic solid organ tumor including but not limited to the following histology: Non-Small Cell Lung cancer (NSCLC), Gastrointestinal cancer (GI), Breast cancer (BC), Gynecological cancers (GYN). Date of histology should be not older than 18 months from the start of the screening procedures. Additionally 30 patients will be enrolled in 4 expansion cohorts: 1) refractory metastatic Colorectal cancer (mCRC) patients who have failed prior treatment with standard chemotherapeutics and both anti-VEGF and anti-EGFR antibodies; 2) patients with recurrent and/or metastatic Head and Neck cancers, who have failed prior treatment with a checkpoint inhibitor and at least one line of chemotherapy as appropriate depending on the histology and platinum-elegibility; salivary gland tumors can be enrolled in this cohort after failure of at least one line of chemotherapy; 3) refractory metastatic NonSmall Cell Lung cancer (NSCLC) patients who have failed all standard treatment options including chemotherapy, tyrosine kinase inhibitors and immunotherapy as appropriate depending on the histology and mutational status, 4) refractory metastatic Breast cancer (BC) patients who have failed all standard treatment options including chemotherapy, hormone therapy and anti-human epidermal growth factor receptor 2 [HER2] treatment as appropriate depending on the histology.
- Patients are required to have a positive EGFR IHC expression (≥25% of tumor cells) as assessed by local laboratory. This condition will not be required anymore in the additional 30 patients of the expansion cohorts
- Measurable disease according to RECIST 1.1. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have a short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines
- Failure of standard therapy or non-availability of standard therapy (patients must have received at least one line of chemotherapy and further standard therapy is not an option at study entry)
Key exclusion criteria (30 listed)
- First 20 patients: Known activating EGFR mutation. This exclusion criterion will no more apply for the 30 additional patients of the expansion cohorts.
- Involvement in the planning and/or conduct of the study (applies to both Glycotope staff and/or staff at the study site)
- Concurrent enrolment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study
- Patients institutionalized by official means or court order.
- Chemotherapy, radiation, or any other anti-cancer therapies, including any investigational agent, within 4 weeks prior start of study treatment
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 |
|---|---|---|
| First part: Gatipotuzumab and Tomuzotuximab; Second part: Gatipotuzumab and Tomuzotuximab or anti-EGFR antibody (Cetuximab, Panitumumab or Necitumumab)Also: PankoMab-GEX (GAT) and CetuGEX (TOM)Two monoclonal antibodies, Gatipotuzumab is anti-TAMUC1, Tomuzotuximab is anti-EGFR | Drug | Combination |
Primary outcome
Safety: Incidence and Severity of adverse events (AEs) and IRRs
Time frame: 12 months
Incidence of adverse events (AEs) and IRRs
Overall tolerability
Time frame: 12 months
Standard safety assessments in terms of laboratory evaluations, vital signs, electrocardiogram [ECG], and physical examinations
3 secondary outcomes
Efficacy of the combined treatment: Objective response rate (ORR)
Time frame: 12 months
Immunogenicity of combined Treatment: incidence of anti-drug antibodies (ADAs)
Time frame: 12 months
Pharmacokinetics (PK) of combined Treatment: Concentration
Time frame: 12 months
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 12 Jul 2021.
- Derived from this study: PubMed 35397434Ochsenreither S, Fiedler WM, Conte GD, Macchini M, Matos I, Habel B, Ahrens-Fath I, Raspagliesi F, Lorusso D, Keilholz U, Rolling C, Kebenko M, Klinghammer KF, Saavedra O, Baumeister H, Zurlo A, Garralda E. Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors. ESMO Open. 2022 Apr;7(2):100447. doi: 10.1016/j.esmoop.2022.100447. Epub 2022 Apr 6.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor, Adult
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
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.
Sebastian Ochsenreither, Dr. med. principal investigator
Charité Benjamin Franklin Comprehensive Cancer Center,Hindenburgdamm 30,12200/12203 Berlin, Germany
4 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 First part: Gatipotuzumab and Tomuzotuximab; Second part: Gatipotuzumab and Tomuzotuximab or anti-EGFR antibody (Cetuximab, Panitumumab or Necitumumab) in people with Solid Tumor, Adult, run by Glycotope GmbH at 4 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 15 inclusion and 30 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 12 Jul 2021. 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, Italy, Spain. 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?
Safety: Incidence and Severity of adverse events (AEs) and IRRs (time frame: 12 months). The study lists 2 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 NCT03360734, 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 12 Jul 2021.