Locally Advanced or Metastatic Urothelial Cell Carcinoma Clinical Trial
Official title:
A Dose Escalation, Expansion Study of Vofatamab (B-701) Alone, Plus Docetaxel, or Versus Docetaxel in Subjects With Locally Advanced or Metastatic Urothelial Cell Carcinoma Who Have Relapsed After, or Are Refractory to Standard Therapy
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).
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. Vofatamab is a novel monoclonal antibody specific for fibroblast growth factor
receptor 3 (FGFR3) that is being developed to target FGFR3-positive tumors.
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).
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 2 | |
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