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Clinical Trials List

Protocol NumberB-701-U21
NCT Number(ClinicalTrials.gov Identfier)NCT02401542
Completed

2017-11-01 - 2022-12-31

Phase I/II

Terminated9

ICD-10C79.10

Secondary malignant neoplasm of unspecified urinary organs

ICD-10C79.11

Secondary malignant neoplasm of bladder

ICD-10C79.19

Secondary malignant neoplasm of other urinary organs

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9198.1

Secondary malignant neoplasm of other urinary organs

A Phase 1b/2, Randomized, Double-Blind, PlaceboControlled, 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

  • Trial Applicant

    MEDPACE TAIWAN LIMITED

  • Sponsor

    BioClin Therapeutics, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/15

Investigators and Locations

Principal Investigator 余家政 Division of Urology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Hsiao-Jen Chung Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator MING-CHE LIU Division of Urology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator
Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 歐宴泉 Division of Urology
童綜合醫療社團法人童綜合醫院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wen-Pin Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 江博暉 Division of Urology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chao-Hsiang Chang Division of Urology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Po-Jung Su
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Locally Advanced or Metastatic Urothelial Cell Carcinoma Urinary Bladder Disease Urological Diseases

Objectives

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).

Test Drug

B-701

Active Ingredient

B-701

Dosage Form

N/A

Dosage

50 mg or 100 mg

Endpoints

Primary Efficacy Outcome: Progression Free Survival (PFS) Efficacy of vofatamab plus docetaxel, compared with docetaxel plus placebo, and vofatamab alone as measured by PFS; measured from randomization to first occurrence of disease progression (per RECIST v1.1) or death, whichever occurs first. A patient has had to receive at least one vofatamab dose. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. 3-4 years

Inclution Criteria

Stage IV, locally advanced or metastatic (T4b, any N; or any T, N2-3) urothelial bladder cancer or TCC arising in another location of the urinary tract, including urethra, ureter, and renal pelvis
Histological or cytological diagnosis of UCC.
Relapsed after or are refractory to at least one prior line of chemotherapy which has not included a taxane (with the exception of Cohort 3 of Phase 2 and Phase 2b Monotherapy Expansion of Phase 2b which will allow the enrollment of patients with prior treatment with a taxane)
Subjects must have received at least one prior chemotherapeutic regimen (at least one cycle each) for advanced or metastatic/recurrent disease, of which at least one regimen included a platinum agent (unless contraindicated).
Prior neoadjuvant or adjuvant chemotherapy (without a taxane, except Cohort 3 of Phase 2 and Phase 2b Monotherapy Expansion, which will allow the enrollment of subjects with prior treatment with a taxane) is permitted and will not be counted as first-line chemotherapy, as long as the subject has not progressed within 12 months of the last dose.
Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Phase 2 and Phase 2b Specific Inclusion Criteria:

Patient must be confirmed to have a FGFR3 genomic alteration at the time of documentation of advanced disease.
Relapsed after or are refractory to an immune checkpoint inhibitor. This inclusion criterion does not apply if the checkpoint inhibitor is contraindicated.

Exclusion Criteria

N/A

The Estimated Number of Participants

  • Taiwan

    45 participants

  • Global

    261 participants

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