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

A Phase 1, First-in-man, Multicenter, Open-label, Dose-escalation Study of Single-agent GBR 1302 in Subjects With HER2 Positive Cancers

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

Study Overview

• Status: Terminated
• Conditions: HER2 Expressing Solid Tumours
• Intervention / Treatment: Drug: CD3/HER2 bispecific monoclonal antibody

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Glenmark Investigational Site 103
  • Cologne, Germany, 50670
    • Glenmark Investigational Site 102
  • Dresden, Germany, 01307
    • Glenmark Investigational Site 101
  • Mainz, Germany, 55131
    • Glenmark Investigational Site 104
• United States
  • Kansas
    • Fairway, Kansas, United States, 66205
      • Glenmark Investigational Site 204
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Glenmark Investigational Site 209
  • Texas
    • Dallas, Texas, United States, 75230
      • Glenmark Investigational Site 201
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Glenmark Investigational Site 203

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Tolerated Dose (MTD) of GBR 1302	Number of DLTs (dose limiting toxicities) after the first two administrations of study drug (i.e. Cycle 1) in each cohort	28 Days
The relationship of the dose of GBR 1302 with the incidence, nature, and intensity of AEs according to CTCAEv4.03		28 Days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ichnos Sciences SA
• Collaborators: Glenmark Pharmaceuticals S.A.
• Investigators: Study Director: Mikhail Khazan, MD, Ichnos Sciences SA

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: July 1, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Monoclonal; Antibodies, Bispecific
• Other Study ID Numbers: GBR 1302-101; 2015-002926-38 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No