drugset / Trial / NCT00868595
MTD Study of Vaccine BP-GMAX-CD1 Plus AP1903 to Treat Castrate Resistant Prostate Cancer
Phase 1
Completed
18 enrolled
Bellicum Pharmaceuticals
Baylor College of Medicine · collabM.D. Anderson Cancer Center · collabMemorial Hermann Hospital · collabThe University of Texas Health Science Center, Houston · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase I, non-randomized, multiple-dose, 3+3 dose-escalation study of the safety, pharmacokinetics, biomarkers, preliminary efficacy and patient-reported outcomes of therapeutic vaccine, BPX-101 (formerly BP-GMAX-CD1), plus activating agent, AP1903, in patients with castrate resistant prostate cancer.
Timeline
- Start
- 2009-04
- Primary completion
- 2011-07
- Completion
- 2012-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BPX-101 | Vaccine | 4e+06 cells | Intravitreal |
| Subject | BPX-101 | Vaccine | 1.25e+07 cells | Intravitreal |
| Subject | BPX-101 | Vaccine | 2.5e+07 cells | Intravitreal |
| Subject | Rimiducid | Other / unclassified | 0.4 mg/kg | Intravenous |