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
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
Drug | Synonyms | Arms |
---|
CD3/HER2 bispecific monoclonal antibody | | GBR 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
Name | Type | Description | Interventions |
---|
GBR 1302 | Experimental | Dose 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: | Terminated |
Lead Sponsor: | Ichnos Sciences SA |
Last Updated
October 9, 2020