Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Locally Advanced or Metastatic Urothelial Cell Carcinoma, Urinary Bladder Disease, Urological Diseases
In brief
This is a Phase 1/2(b), sequential, dose escalation, open-label, randomized expansion, multicenter, efficacy and safety study of vofatamab alone or in combination with docetaxel, or versus docetaxel in FGFR3 mutant/fusion subjects with Stage IV, locally advanced or metastatic UCC who have relapsed after, or are refractory to at least one prior line of chemotherapy. This study is divided into 3 phases: Phase 1b (Cohort 1), Phase 2 (Cohorts 2 and 3), and Phase 2b (Monotherapy Expansion Phase and Randomized Phase).
Key facts
- Study ID
- NCT02401542
- Run by
- Rainier Therapeutics
- People needed
- 71
- Starts
- 2015-06-01
- Expected to finish
- 2019-11-01
- Last updated by the study team
- 2020-03-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Goodyear, Arizona, United States
- Research Site — Duarte, California, United States
- Research Site — Miami, Florida, United States
- Reaserach Site — Fort Wayne, Indiana, United States
- Research Site — Louisville, Kentucky, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Detroit, Michigan, United States
- Research Site — Rochester, Minnesota, United States
- Research Site — Syracuse, New York, United States
- Research Site — Dallas, Texas, United States
- Research Site — Olomouc, Czechia
- Research Site — Prague, Czechia
- Research Site — Ancona, Italy
- Research Site — Catania, Italy
- Research Site — Milan, Italy
- Research Site — Milan, Italy
- Research Site — Milan, Italy
- Research Site — Modena, Italy
- Research Site — Naples, Italy
- Research Site — Negrar, Italy
- Research Site — Siena, Italy
- Research Site — Gwangju, South Korea
- Research Site — Incheon, South Korea
- Research Site — Seongnam-si, South Korea
- Research Site — Gilbert, Arizona, United States
Full record on ClinicalTrials.gov
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