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

NCT02829372 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: GBR 1302-1012015-002926-38
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 8

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

Conditions

HER2 Expressing Solid Tumours

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (1)

GBR 1302

EXPERIMENTAL

Dose escalation

Drug: CD3/HER2 bispecific monoclonal antibody

Interventions

CD3/HER2 bispecific monoclonal antibody DRUG

Increasing doses, IV on day 1 and 15 of each 28 day cycle

GBR 1302

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Active infectious disease considered by the Investigator to be incompatible with the protocol.
• 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.
• Brain metastases that are symptomatic or untreated or that require current therapy.
• 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.
• 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.

Sponsors & Collaborators

• Ichnos Sciences SA: lead
• Glenmark Pharmaceuticals S.A.: collaborator

Study Sites (8)

Glenmark Investigational Site 204

Fairway, Kansas, 66205, United States

Location

Glenmark Investigational Site 209

Detroit, Michigan, 48201, United States

Location

Glenmark Investigational Site 201

Dallas, Texas, 75230, United States

Location

Glenmark Investigational Site 203

Salt Lake City, Utah, 84112, United States

Location

Glenmark Investigational Site 103

Berlin, 10117, Germany

Location

Glenmark Investigational Site 102

Cologne, 50670, Germany

Location

Glenmark Investigational Site 101

Dresden, 01307, Germany

Location

Glenmark Investigational Site 104

Mainz, 55131, Germany

Location

Study Officials

• Mikhail Khazan, MD

  Ichnos Sciences SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 12, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: October 9, 2020

Record last verified: 2020-10

Locations

US (4); DE (4)