Clinical Trials /

Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers

NCT02829372

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase 1 Study of Single Agent GBR 1302 in Subjects With HER2 Positive Cancers
  • 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

Clinical Trial IDs

  • ORG STUDY ID: GBR 1302-101
  • SECONDARY ID: 2015-002926-38
  • NCT ID: NCT02829372

Conditions

  • HER2 Expressing Solid Tumours

Interventions

DrugSynonymsArms
CD3/HER2 bispecific monoclonal antibodyGBR 1302

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
GBR 1302ExperimentalDose escalation
  • CD3/HER2 bispecific monoclonal antibody

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximal Tolerated Dose (MTD) of GBR 1302
Time Frame:28 Days
Safety Issue:
Description:Number of DLTs (dose limiting toxicities) after the first two administrations of study drug (i.e. Cycle 1) in each cohort

Secondary Outcome Measures

Measure:Objective Response Rate (ORR) for solid tumors.
Time Frame:2 cycles, 56 days
Safety Issue:
Description:
Measure:Disease control rate (DCR) for solid tumors
Time Frame:2 cycles, 56 days
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Maximum Concentration (Cmax) of GBR 1302
Time Frame:28 Days
Safety Issue:
Description:
Measure:Time to Maximum Concentration (Tmax) of GBR 1302
Time Frame:28 Days
Safety Issue:
Description:
Measure:Area Under Curve [AUC0-t and AUC0-tau] of GBR 1302
Time Frame:28 Days
Safety Issue:
Description:
Measure:Immunogenicity of GBR 1302 in terms of ADA formation assessed compared to baseline
Time Frame:28 Days
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Glenmark Pharmaceuticals S.A.

Last Updated

March 27, 2018