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Trial record 7 of 9 for:    glycotope

Combination of Gatipotuzumab and Tomuzotuximab in Patients With Solid Tumors (GATTO)

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ClinicalTrials.gov Identifier: NCT03360734
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Glycotope GmbH

Brief Summary:
This is a single arm phase Ib study. The purpose of this study is to evaluate the safety and efficacy of a combined therapy with Tomuzotuximab and Gatipotuzumab in patients with solid tumors expressing EGFR, for whom no standard treatment is available.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Biological: Gatipotuzumab and Tomuzotuximab Phase 1

Detailed Description:

Tomuzotuximab (CetuGEX®) is an improved second-generation anti-EGFR antibody that specifically binds to EGFR and acts as a competitive antagonist at the ligand binding site of EGFR.

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 to the TA-MUC1 epitopes on the surface of tumor cells, which may potentially activate the immune system to induce antibody-dependent cellular cytotoxicity (ADCC) against the TA MUC1 expressing tumor cells.

Based on the compelling preclinical evidence suggesting a complex interaction between EGFR and TA-MUC1 expressed on the tumor cell surface in driving cancerogenesis, this study aims to assess the tolerability, safety and preliminary activity of targeting EGFR and TA-MUC1 with glyco-engineered antibodies.

The initial recruitment will be staggered to allow assessment of the tolerability of the initial dose. In order to continue enrollment, the number of DLTs will be evaluated in the first 6 patients. If observed number of DLTs is <2, the dose will remain unchanged and further patients will be recruited at this dose level. Otherwise the step-wise dose reduction approach will apply.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Study to Evaluate the Safety, Tolerability and Efficacy of Gatipotuzumab and Tomuzotuximab Combination in Patients With Solid Tumors
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
Experimental: Combination
Combination of Gatipotuzumab and Tomuzotuximab
Biological: Gatipotuzumab and Tomuzotuximab
Two monoclonal antibodies, Gatipotuzumab is anti-TAMUC1, Tomuzotuximab is anti-EGFR




Primary Outcome Measures :
  1. Safety: Incidence of adverse events (AEs) [ Time Frame: 12 months ]
    Incidence of adverse events (AEs)


Secondary Outcome Measures :
  1. Efficacy of the combined treatment: Objective response rate (ORR) [ Time Frame: 12 months ]
    Objective response rate (ORR)

  2. Immunogenicity of Gatipotuzumab in combination with Tomuzotuximab: incidence of anti-drug antibodies (ADAs) [ Time Frame: 12 months ]
    incidence of anti-drug antibodies (ADAs)

  3. Pharmacokinetics (PK): Concentration [ Time Frame: 12 months ]
    Concentration



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female and age ≥18 years
  2. Histologically confirmed locally advanced and/or metastatic solid organ tumor including but not limited to the following histology: Non-Small Cell Lung cancer (NSCLC), Colorectal cancer (CRC), Breast cancer (BC), Gynecological cancers (GYN).
  3. Patients are required to have a positive EGFR IHC expression
  4. Measurable disease according to RECIST 1.1.
  5. Failure of standard therapy or non-availability of standard therapy
  6. Prior treatment with any anti-EGFR agent should have been completed at least 4 months before start of treatment
  7. Toxicities, except for alopecia and Grade 2 neuropathy, should be not greater than Grade 1 before start of treatment
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 and estimated life expectancy of ≥3 months
  9. Adequate organ function d. Cardiologic function: LVEF fraction ≥ 50%
  10. 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
  11. Written informed consent obtained prior to conducting any study specific procedures

Exclusion Criteria:

  1. Known activating EGFR mutation
  2. Involvement in the planning and/or conduct of the study (applies to both Glycotope staff and/or staff at the study site)
  3. Concurrent enrolment in another clinical study
  4. Patients institutionalized by official means or court order.
  5. Chemotherapy, radiation, or any other anti-cancer therapies, including any investigational agent, within 4 weeks prior to study enrollment
  6. Concurrent anti-tumor therapy or concurrent immunotherapy
  7. Current or prior use of immunosuppressive medication within 28 days before the first dose of study drug.
  8. Major surgery within 4 weeks prior to entering the study
  9. Primary or secondary immune deficiency requiring treatment.
  10. Clinically active infections >Grade 2 according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE v. 4.0)
  11. Prior allergic reaction to a monoclonal antibody (e.g., trastuzumab, Cetuximab, or bevacizumab)
  12. Clinical signs of brain metastasis or leptomeningeal involvement
  13. 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
  14. History of seizures, encephalitis, or multiple sclerosis
  15. Active drug abuse or chronic alcoholism
  16. Pregnant or breastfeeding
  17. Known sensitivity to any component of the test products
  18. Contraindication to the premedication used in this study (H1 and/or H2 receptor antagonists and steroids)
  19. Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360734


Locations
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Germany
Glycotope-contracted research facility Recruiting
Berlin, Germany, 1xxxx
Contact: Medical Director    +493094892600    info@glycotope.com   
Glycotope-contracted research facility Recruiting
Hamburg, Germany, 2xxxx
Contact: Medical Director    +493094892600    info@glycotope.com   
Italy
Glycotope-contracted research facility Not yet recruiting
Milan, Italy, 02100
Contact: Medical Director    +493094892600    info@glycotope.com   
Glycotope-contracted research facility Not yet recruiting
Milan, Italy, 02100
Contact: Medical Director    +4903094892600    info@glycotope.com   
Spain
Glycotope-contracted research facility Recruiting
Barcelona, Spain, xxxxx
Contact: Medical Director    +493094892600    info@glycotope.com   
Sponsors and Collaborators
Glycotope GmbH

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Responsible Party: Glycotope GmbH
ClinicalTrials.gov Identifier: NCT03360734     History of Changes
Other Study ID Numbers: 5225101
2017-001609-33 ( EudraCT Number )
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No