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Clinical Trials List

Protocol NumberFIERCE-21 (B-701-U21)
NCT Number(ClinicalTrials.gov Identfier)NCT02401542

2017-11-01 - 2022-12-31

Phase I/II

Terminated8

ICD-10C67.9

Malignant neoplasm of bladder, unspecified

ICD-10C67

Malignant neoplasm of bladder

ICD-9198.1

Secondary malignant neoplasm of other urinary organs

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.

  • Trial Applicant

    MEDPACE TAIWAN LIMITED

  • Sponsor

    Rainier Therapeutics

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

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 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 余家政 Division of Urology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 歐宴泉 Division of Urology
Kuang Tien 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

Audit

None

Principal Investigator Chao-Hsiang Chang 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Po-Jung Su Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Taiwan National PI

See-Tong Pang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

3 Terminated

Audit

None

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

Audit

None

Condition/Disease

Locally Advanced or Metastatic Urothelial Cell Carcinoma

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

Vofatamab (B-701)

Active Ingredient

Vofatamab (B-701)

Dosage Form

IV infusion

Dosage

100 mg

Endpoints

Primary Efficacy Outcome: Progression Free Survival (PFS)

Inclution Criteria

1.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
2.Histological or cytological diagnosis of UCC.
3.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)
4.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).
5.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.
6.Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Exclusion Criteria

1.Prior anti-cancer therapy within 2 weeks prior to Cycle 1, Day 1
2.Prior treatment with an inhibitor that is targeted primarily to FGFRs
C3.linically significant comorbid medical conditions or lab abnormalities
4.History of major bleeding (requiring a blood transfusion ≥ 2 units) not related to a tumor within the past 12 months
5.History of clinically significant coagulation or platelet disorder in the past 12 months
6.Currently receiving anticoagulation treatment
7.Incomplete healing from wounds from prior surgery
8.Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at screening
9.Presence of positive test results for Hepatitis B or Hepatitis C
10.Known history of human immunodeficiency virus (HIV) seropositive status

The Estimated Number of Participants

  • Taiwan

    45 participants

  • Global

    300 participants

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