Description:
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).
A Phase 2 Study of <span class="go-doc-concept go-doc-intervention">B-701</span> in Treatment of Locally Advanced or Metastatic <span class="go-doc-concept go-doc-disease">Urothelial Cell Carcinoma</span>
Title
Brief Title: A Phase 2 Study of B-701 in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of B-701 Plus Docetaxel Versus Placebo Plus Docetaxel in the Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma in Subjects Who Have Relapsed After, or Are Refractory to Standard Therapy
Clinical Trial IDs
NCT ID: NCT02401542
ORG ID: B-701-U21
Trial Conditions
Locally Advanced or Metastatic Urothelial Cell Carcinoma
Urinary Bladder Disease
Urological Diseases
Trial Interventions
| Drug |
Synonyms |
Arms |
| B-701 |
|
B-701 plus docetaxel |
| Docetaxel |
|
B-701 plus docetaxel, Placebo plus docetaxel |
| placebo |
|
Placebo plus docetaxel |
Trial Purpose
This is a phase 2, randomized, double-blind, placebo-controlled, multicenter, parallel-group
study of B-701 plus docetaxel versus placebo plus docetaxel in the treatment of locally
advanced or metastatic urothelial cell carcinoma in subjects who have relapsed after, or are
refractory to standard therapy.
Detailed Description
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter,
parallel-group, efficacy and safety study of B-701 plus docetaxel versus placebo plus
docetaxel in the treatment of subjects with Stage IV, locally advanced or metastatic
urothelial cell carcinoma (UCC) who have relapsed after, or are refractory to one or two
prior lines of chemotherapy which have not included a taxane. This study is divided into two
phases: Lead-In Phase and Randomized Phase. For subjects in the Lead-In Phase, the
inclusion/exclusion criteria, visits and procedures are identical to those treated with
B-701 in the Randomized Phase.
Trial Arms
| Name |
Type |
Description |
Interventions |
| B-701 plus docetaxel |
Active Comparator |
IV infusion B-701, 25 mg/kg plus docetaxel, 75 mg/m2 on day one of each 21-day cycle |
B-701, Docetaxel |
| Placebo plus docetaxel |
Placebo Comparator |
IV infusion placebo plus docetaxel, 75 mg/m2 on day one of each 21-day cycle |
Docetaxel, placebo |
Eligibility Criteria
Key Inclusion Criteria:
- Provide tumor tissue obtained within 18 months of enrollment of suitable quality and
quantity and to demonstrate FGFR3 positive tumor by IHC. For subjects participating
in the Randomized Phase only, if suitable archival tissue is unavailable, then a core
biopsy of tumor tissue (metastatic or primary) must be obtained prior to
randomization
- Stage IV, locally advanced or metastatic urothelial bladder cancer or transitional
cell carcinoma arising in another location of the urinary tract, including urethra,
ureter, and renal pelvis
- Relapsed after or are refractory to one or two prior lines of chemotherapy which have
not included a taxane platinum agent, as long as a platinum agent is not
contraindicated for the subject (i.e., if a platinum agent is contraindicated for a
subject, the one or two prior regimen need not have included a platinum agent)
- Measurable disease according to RECIST v1.1 criteria
- 18 years old
- ECOG 0 or 1
Main Exclusion Criteria:
- Prior anti-cancer therapy within 4 weeks prior to Cycle 1, Day 1
- Weight > 100kg
- Clinically significant comorbid medical conditions or lab abnormalities
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Primary Outcome Measures
Evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel as measured by progression-free survival (PFS)
Evaluate the safety and tolerability of B-701 plus docetaxel compared with placebo plus docetaxel in the treatment of subjects with UCC as measured by AEs
Evaluate the safety and tolerability of B-701 plus docetaxel compared with placebo plus docetaxel in the treatment of subjects with UCC as measured by physical examinations.
Evaluate the safety and tolerability of B-701 plus docetaxel compared with placebo plus docetaxel in the treatment of subjects with UCC as measured by laboratory results.
Evaluate the safety and tolerability of B-701 plus docetaxel compared with placebo plus docetaxel in the treatment of subjects with UCC as measured by electrocardiogram (ECG) results.
Secondary Outcome Measures
Evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel as measured by objective response rates (ORR)
Evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel as measured by disease control rate (DCR)
Evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel as measured by duration of objective response (DOR)
Evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel as measured by overall survival (OS)
Evaluate the efficacy of B-701 plus docetaxel compared with placebo plus docetaxel as measured by quality of life (QOL)
Trial Keywords
Urothelial Cell Carcinoma
UCC
bladder cancer
B-701
FGFR3
invasive bladder cancer
targeted therapy
Transitional Cell Carcinoma
TCC
Phase 2
second line therapy
monoclonal antibody
docetaxel
combination therapy
