Clinical Trials /

Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma

NCT02401542

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).

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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