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ISB 1302 in HER2-positive metastatic breast cancer
NCT03983395Phase 2
Key facts
- Status
- Terminated
- Start
- Apr 2020
- Primary completion
- Jul 2020
- Countries
- 1
- Sponsor
- Ichnos Sciences Inc.
- Modality
- Bispecific Antibodies, T-cell Engagers
- Drugs
- GBR 1302
- Conditions
- HER2-positive breast cancer
01
Overview
Phase 2, open-label trial of GBR 1302 in HER2-positive breast cancer (8 arms), sponsored by Ichnos Sciences Inc. Primary endpoints: Maximum Tolerated Dose at 28 days, Recommended Phase 2 Dose up to 6 months and 1 more. Started Apr 2020; status: terminated.
02
Design
8 arms- Study design
- Non-randomizedOpen-label
Cohort 101
ISB 1302 250 ng/kg
Cohort 201
ISB 1302 325 ng/kg
Cohort 301
ISB 1302 325 -> 425 ng/kg
Cohort 401
ISB 1302 325 -> 550 ng/kg
Cohort 501
ISB 1302 325 -> 550 -> 700 ng/kg
Cohort 601
ISB 1302 325 -> 550 -> 900 ng/kg
2 more in the full profile.
03
Who it enrols
Females with HER2-positive metastatic breast cancer who have progressed on last therapy, with no more than 4 prior lines of therapy in the metastatic setting.
04
Endpoints
Primary
Maximum Tolerated Dose
Recommended Phase 2 Dose
Anti-tumor Activity
Secondary
Adverse Events
Anti-tumor Activity (Part 1)
Maximum Plasma Concentration
Immunogenicity
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