drugset / Trial / NCT02117362
Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
Phase 1
Completed
8 enrolled
Providence Health & Services
Galectin Therapeutics Inc. · collabProvidence Cancer Center, Earle A. Chiles Research Institute · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The goal of this study is to determine a safe dose of GR-MD-02 used in combination with the FDA-approved dose of ipilimumab (3 mg/kg) in patients who have advanced melanoma. GR-MD-02 is a galectin. Galectins are a family of proteins that have numerous functions in normal mammalian biology including the facilitation of cell-cell interactions, regulation of cell-death and regulation of immune system responses. The hypothesis is that a safe dose of GR-MD-02 when given with the FDA-approved dose of ipilimumab can be found.
Timeline
- Start
- 2014-05-08
- Primary completion
- 2018-11-28
- Completion
- 2018-11-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | belapectin | Other / unclassified | 1 mg/kg | — |
| Subject | belapectin | Other / unclassified | 2 mg/kg | — |
| Subject | belapectin | Other / unclassified | 4 mg/kg | — |
| Subject | belapectin | Other / unclassified | 8 mg/kg | — |
| Background | Ipilimumab | Monoclonal antibody | 3 mg/kg | — |