Locally Advanced or Metastatic Urothelial Cell Carcinoma Clinical Trial
Official title:
A Multi-Center, Open-Label Phase 1b/2 Study of a Novel FGFR3 Inhibitor (B-701) Combined With Pembrolizumab in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Who Have Progressed Following Platinum-based Chemotherapy
This is a Phase 1b/2 multi-center, open-label study to establish the initial safety and to determine a recommended Phase 2 dose of B-701 in combination with pembrolizumab, and to determine safety, tolerability and efficacy of B-701 (vofatamab) plus pembrolizumab in the treatment of subjects with locally advanced or metastatic UCC, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.
This is a Phase 1b/2 multi-center, open-label study to determine the safety, tolerability,
and efficacy of B-701 (vofatamab) plus pembrolizumab in the treatment of subjects with
locally advanced or metastatic UCC, who have progressed following platinum-based chemotherapy
and who have not received prior immune checkpoint inhibitor or FGFR inhibitor-targeted
therapy. The study consists of 2 parts: a Phase 1b lead-in phase enrolling 6 to 18 subjects
and a Phase 2 dose expansion phase enrolling up to a total of 74 subjects.
Subjects who discontinue B-701 (vofatamab) may continue on study and receive pembrolizumab
alone until disease progression, death, withdrawal of patient consent, or study termination.
Subjects who discontinue pembrolizumab may continue on study and receive B-701 (vofatamab)
alone until disease progression, death, withdrawal of patient consent, or study termination.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01613586 -
A Randomized Study Comparing Placebo and ASP3652 in the Treatment of Women With Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC)
|
Phase 2 | |
| Terminated |
NCT02401542 -
Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma
|
Phase 1/Phase 2 |