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History of Changes for Study: NCT02829372
Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers (GBR 1302-101)
Latest version (submitted October 8, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 7, 2016 None (earliest Version on record)
2 April 28, 2017 Study Status, Contacts/Locations, Eligibility, Outcome Measures and Study Design
3 February 5, 2018 Contacts/Locations and Study Status
4 March 27, 2018 Study Status and Contacts/Locations
5 December 10, 2018 Study Status and Contacts/Locations
6 April 26, 2019 Recruitment Status, Study Status and Contacts/Locations
7 December 9, 2019 Recruitment Status, Study Status and Contacts/Locations
8 December 10, 2019 Recruitment Status, Study Status, Study Design and Study Identification
9 December 15, 2019 Recruitment Status and Study Status
10 December 17, 2019 Study Status
11 December 20, 2019 Study Identification, Outcome Measures, Arms and Interventions, Contacts/Locations, Study Description, Sponsor/Collaborators and Study Status
12 December 23, 2019 Sponsor/Collaborators and Study Status
13 January 29, 2020 Study Identification, Oversight, Sponsor/Collaborators, Outcome Measures, Arms and Interventions, Contacts/Locations, Study Description and Study Status
14 October 8, 2020 Study Status and Contacts/Locations
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Study NCT02829372
Submitted Date:  July 7, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: GBR 1302-101
Brief Title: Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers (GBR 1302-101)
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
Secondary IDs: 2015-002926-38 [EudraCT Number]
Open or close this module Study Status
Record Verification: July 2016
Overall Status: Recruiting
Study Start: May 2016
Primary Completion: November 2018 [Anticipated]
Study Completion:
First Submitted: July 1, 2016
First Submitted that
Met QC Criteria:
July 7, 2016
First Posted: July 12, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 7, 2016
Last Update Posted: July 12, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Glenmark Pharmaceuticals S.A.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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
Detailed Description:
Open or close this module Conditions
Conditions: HER2 Expressing Solid Tumours
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: GBR 1302
Dose escalation
Drug: CD3/HER2 bispecific monoclonal antibody
Increasing doses, IV on day 1 and 15 of each 28 day cycle
Open or close this module Outcome Measures
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: 28 Days ]

2. Disease control rate (DCR) for solid tumors
[ Time Frame: 28 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: 28 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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
  3. Subjects who will enter Cohort 1 or 2 need a pre-existing, functioning, central venous access in place for the administration of the study drug.

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.
  6. Any history or evidence of clinically significant cardiovascular disease defined as at least one of following criteria:
    1. Baseline Left Ventricular Ejection Fraction (LVEF) < 50% or major wall dyskinesias via echocardiography (ECHO).
    2. History or evidence of poorly controlled arterial hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure >100 mmHg).
    3. Cardiac arrhythmias requiring anti-arrhythmic therapy, except for betablockers, calcium antagonists and digoxin.
    4. Clinically significant valvular heart disease.
    5. Myocardial infarction or instable angina pectoris within the previous 6 months.
    6. Documented history of congestive heart failure (CHF) of any New York Heart Association (NYHA) criteria.
    7. History of exposure to the cumulative doses of anthracyclines as follows: prior anthracycline cumulative exposure > 360 mg/m2 of doxorubicin or its equivalent.
  7. Known allergy to any of the ingredients in the formulation or known allergy to any related class of compounds.
Open or close this module Contacts/Locations
Central Contact Person: Robert Joseph, Ph.D.
Telephone: 201-762-2165
Email: Robert.Joseph@glenmarkpharma.com
Study Officials: Eliel Bayever, MBBCh, MRCP
Study Director
Glenmark Pharmaceutical S.A
Locations: Germany
Glenmark Investigational Site 103
[Recruiting]
Berlin, Germany, 10117
Contact:Contact: Dr Sebastian Ochsenreither, MD +49 30 450 564 621 sebastian.ochsenreither@charite.de
Glenmark Investigational Site 102
[Recruiting]
Cologne, Germany, 50670
Contact:Contact: Prof Helmuth Schmidt, MD +49 221 4545-900 H.Schmidt@cellex.me
Glenmark Investigational Site 101
[Recruiting]
Dresden, Germany, 01307
Contact:Contact: Dr Martin Wermke, MD +49 351 458-4695 martin.wermke@uniklinikum-dresden.de
Glenmark Investigational Site 104
[Recruiting]
Mainz, Germany, 55131
Contact:Contact: Dr Hildegard Nolte, MD +49 6131 17-5950 hildegard.nolte@unimedizin-mainz.de
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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