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Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers (GBR 1302-101)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02829372
Recruitment Status : Terminated (Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention)
First Posted : July 12, 2016
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
Glenmark Pharmaceuticals S.A.
Information provided by (Responsible Party):
Ichnos Sciences SA

Study Description
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Brief Summary:
The purpose of this study is to determine the safety profile and maximum tolerable dose (MTD) of GBR 1302 monotherapy in subjects with HER2 positive cancers

Condition or disease Intervention/treatment Phase
HER2 Expressing Solid Tumours Drug: CD3/HER2 bispecific monoclonal antibody Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-man, Multicenter, Open-label, Dose-escalation Study of Single-agent GBR 1302 in Subjects With HER2 Positive Cancers
Actual Study Start Date : May 2016
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: GBR 1302
Dose escalation
 Drug: CD3/HER2 bispecific monoclonal antibody
Increasing doses, IV on day 1 and 15 of each 28 day cycle


Outcome Measures
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Primary Outcome Measures :
  1. Maximal Tolerated Dose (MTD) of GBR 1302 [ Time Frame: 28 Days ]
    Number of DLTs (dose limiting toxicities) after the first two administrations of study drug (i.e. Cycle 1) in each cohort

  2. The relationship of the dose of GBR 1302 with the incidence, nature, and intensity of AEs according to CTCAEv4.03 [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) for solid tumors. [ Time Frame: 2 cycles, 56 days ]
  2. Disease control rate (DCR) for solid tumors [ Time Frame: 2 cycles, 56 days ]
  3. Duration of disease control (measured from drug start date to the date of disease progression or death for subjects who had CR or PR or SD during treatment). [ Time Frame: At least 56 days ]
  4. Maximum Concentration (Cmax) of GBR 1302 [ Time Frame: 28 Days ]
  5. Time to Maximum Concentration (Tmax) of GBR 1302 [ Time Frame: 28 Days ]
  6. Area Under Curve [AUC0-t and AUC0-tau] of GBR 1302 [ Time Frame: 28 Days ]
  7. Immunogenicity of GBR 1302 in terms of ADA formation assessed compared to baseline [ Time Frame: 28 Days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Progressive HER2 positive solid tumours (immunohistochemistry [IHC] positive or equivocal) with no available standard or curative treatment.
  2. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.

Exclusion Criteria:

  1. Active infectious disease considered by the Investigator to be incompatible with the protocol.
  2. Patients not recovered from any therapy-related toxicities from previous therapies to at least CTCAE ≤ Grade 1 except in case of liver metastases or Gilbert's Syndrome or alopecia.
  3. Brain metastases that are symptomatic or untreated or that require current therapy.
  4. Previous treatment with immunotherapy within 8 weeks of starting study medication, chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies (including HER2 directed therapies) within 4 weeks of starting study medication, or hormone therapy within 2 weeks of starting study medication.
  5. Use of any investigational drug within the past 4 weeks before start of study medication or concomitantly with this study except for investigational immune-stimulatory therapy (e.g. checkpoint-regulator targeted treatment). The minimum washout period should be 8 weeks before starting the study medication.
Contacts and Locations
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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): NCT02829372


Locations
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United States, Kansas
Glenmark Investigational Site 204
Fairway, Kansas, United States, 66205
United States, Michigan
Glenmark Investigational Site 209
Detroit, Michigan, United States, 48201
United States, Texas
Glenmark Investigational Site 201
Dallas, Texas, United States, 75230
United States, Utah
Glenmark Investigational Site 203
Salt Lake City, Utah, United States, 84112
Germany
Glenmark Investigational Site 103
Berlin, Germany, 10117
Glenmark Investigational Site 102
Cologne, Germany, 50670
Glenmark Investigational Site 101
Dresden, Germany, 01307
Glenmark Investigational Site 104
Mainz, Germany, 55131
Sponsors and Collaborators
Ichnos Sciences SA
Glenmark Pharmaceuticals S.A.
Investigators
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Study Director: Mikhail Khazan, MD Ichnos Sciences SA
More Information
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Responsible Party: Ichnos Sciences SA
ClinicalTrials.gov Identifier: NCT02829372    
Other Study ID Numbers: GBR 1302-101
2015-002926-38 ( EudraCT Number )
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antibodies
Antibodies, Monoclonal
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs