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

Phase 1

Terminated

• Conditions: HER2 Expressing Solid Tumours
• Interventions: Drug: CD3/HER2 bispecific monoclonal antibody

• Registration Number: NCT02829372
• Lead Sponsor: Ichnos Sciences SA

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 available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-12
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-08
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GBR 1302	CD3/HER2 bispecific monoclonal antibody	Dose escalation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Glenmark Investigational Site 204; 🇺🇸 Fairway, Kansas, United States

Glenmark Investigational Site 103; 🇩🇪 Berlin, Germany

Glenmark Investigational Site 102; 🇩🇪 Cologne, Germany

Glenmark Investigational Site 203; 🇺🇸 Salt Lake City, Utah, United States

Glenmark Investigational Site 209; 🇺🇸 Detroit, Michigan, United States

Glenmark Investigational Site 101; 🇩🇪 Dresden, Germany

Glenmark Investigational Site 104; 🇩🇪 Mainz, Germany

Glenmark Investigational Site 201; 🇺🇸 Dallas, Texas, United States