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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

Tracking Information
First Submitted Date  ICMJE July 1, 2016
First Posted Date  ICMJE July 12, 2016
Last Update Posted Date October 9, 2020
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2016)
  • 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
  • The relationship of the dose of GBR 1302 with the incidence, nature, and intensity of AEs according to CTCAEv4.03 [ Time Frame: 28 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • Objective Response Rate (ORR) for solid tumors. [ Time Frame: 2 cycles, 56 days ]
  • Disease control rate (DCR) for solid tumors [ Time Frame: 2 cycles, 56 days ]
  • 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 ]
  • Maximum Concentration (Cmax) of GBR 1302 [ Time Frame: 28 Days ]
  • Time to Maximum Concentration (Tmax) of GBR 1302 [ Time Frame: 28 Days ]
  • Area Under Curve [AUC0-t and AUC0-tau] of GBR 1302 [ Time Frame: 28 Days ]
  • Immunogenicity of GBR 1302 in terms of ADA formation assessed compared to baseline [ Time Frame: 28 Days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2016)
  • Objective Response Rate (ORR) for solid tumors. [ Time Frame: 28 Days ]
  • Disease control rate (DCR) for solid tumors [ Time Frame: 28 Days ]
  • 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 ]
  • Maximum Concentration (Cmax) of GBR 1302 [ Time Frame: 28 Days ]
  • Time to Maximum Concentration (Tmax) of GBR 1302 [ Time Frame: 28 Days ]
  • Area Under Curve [AUC0-t and AUC0-tau] of GBR 1302 [ Time Frame: 28 Days ]
  • Immunogenicity of GBR 1302 in terms of ADA formation assessed compared to baseline [ Time Frame: 28 Days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers
Official Title  ICMJE A Phase 1, First-in-man, Multicenter, Open-label, Dose-escalation Study of Single-agent GBR 1302 in Subjects With HER2 Positive Cancers
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HER2 Expressing Solid Tumours
Intervention  ICMJE Drug: CD3/HER2 bispecific monoclonal antibody
Increasing doses, IV on day 1 and 15 of each 28 day cycle
Study Arms  ICMJE Experimental: GBR 1302
Dose escalation
Intervention: Drug: CD3/HER2 bispecific monoclonal antibody
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 10, 2019)
36
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2016)
30
Actual Study Completion Date  ICMJE May 2019
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02829372
Other Study ID Numbers  ICMJE GBR 1302-101
2015-002926-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ichnos Sciences SA
Original Responsible Party Glenmark Pharmaceuticals S.A.
Current Study Sponsor  ICMJE Ichnos Sciences SA
Original Study Sponsor  ICMJE Glenmark Pharmaceuticals S.A.
Collaborators  ICMJE Glenmark Pharmaceuticals S.A.
Investigators  ICMJE
Study Director: Mikhail Khazan, MD Ichnos Sciences SA
PRS Account Ichnos Sciences SA
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP