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BRIEF TITLE: Novel FGFR3 Inhibitor (B-701) Combined With Atezolizumab in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Who Have Progressed Following Platinum-based Chemotherapy

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


  • Org Study ID: B-701-U22
  • Secondary ID: 2017-001292-23
  • NCT ID: NCT03123055
  • NCT Alias:
  • Sponsor: BioClin Therapeutics, Inc. - Industry
  • Source: BioClin Therapeutics, Inc.

Brief Summary

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 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.

Detailed Description


This is a Phase 1b/2 multi-center, open-label study to determine the safety, tolerability,
and efficacy of B-701 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 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 alone until disease
progression, death, withdrawal of patient consent, or study termination.

Overal Status Start Date Phase Study Type
Recruiting April 20, 2017 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Initial safety and determination of recommended Phase 2 dose according to dose-limiting Toxicity

Primary Outcome 1 - Time Frame: 1 year

Primary Outcome 2 - Measure: Safety and tolerability of B-701 plus pembrolizumab

Primary Outcome 2 - Time Frame: 2.5 years

Primary Outcome 3 - Measure: Efficacy of B-701 plus pembrolizumab measured by ORR

Primary Outcome 3 - Time Frame: 2 years

Condition:

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

Eligibility

Criteria:
Key Inclusion Criteria:

1. Have locally advanced (on TNM staging: T4b and any N, or any T and N2-3) or metastatic
transitional cell carcinoma of the urothelium, including of the urinary bladder,
urethra, ureter, and/or renal pelvis. The diagnosis must be histologically or
cytologically confirmed.

2. Have progression during or following platinum-containing chemotherapy or within 12
months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

3. Have available archival tumor or be willing to undergo diagnostic biopsy at screening.
Sample must be of suitable quality and quantity to satisfy group assignment and
biomarker endpoints.

4. Have measurable disease according to Response Evaluation Criteria in Solid Tumors
Version 1.1 (RECIST v1.1).

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.

Key Exclusion Criteria:

1. Participants with a history of idiopathic pulmonary fibrosis, organizing pneumonia,
drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on
the Screening chest CT scan.

2. Prior therapy with an anti-programmed cell death 1 (PD-1) or anti-PD-Ligand 1 agent,
or with an agent directed to another co-inhibitory T-cell receptor or FGFR inhibitor.

3. Patients with autoimmune disease or medical conditions that required systemic
corticosteroids (> 10 mg/day prednisone or its equivalent) or other immunosuppressive
medications or any other form of systemic immunosuppressive therapy within 7 days
prior to the first dose of study treatment. Note: Replacement therapy (e.g.
physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency,
etc.) is not considered a form of systemic treatment.

4. Primary central nervous system (CNS) malignancy or CNS metastases.

5. History of clinically significant coagulation or platelet disorder in the past 12
months.
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: BioClin Therapeutics

Role: Study Chair

Affiliation: Sponsor GmbH

Overall Contact

Name: BioClin Therapeutics

Phone: 925-413-6140

Email: clin-ops@bioclintherapeutics.com

Locations

Facility Status Contact
Research Site
Greenbrae, California 94904
United States
Recruiting BioClin Study Team
925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Fort Wayne, Indiana 46845
United States
Recruiting BioClin Study Team
925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Louisville, Kentucky 40202
United States
Recruiting BioClin Study Team
925-413-6140
clin-ops@bioclintherapeutics.com
Washington University School of Medicine
Saint Louis, Missouri 63110
United States
Recruiting BioClin Therapeutics
925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Cleveland, Ohio 44195
United States
Recruiting BioClin Study Team
925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Philadelphia, Pennsylvania 19107
United States
Recruiting BioClin Study Team
925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Germantown, Tennessee 38138
United States
Recruiting BioClin Study Team
925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Houston, Texas 77030
United States
Recruiting BioClin Study Team
925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Brussel, 1000
Belgium
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Leuven, 3000
Belgium
Recruiting Study Team BioClin Therapeutics
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Team
Yvoir, 5530
Belgium
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Team
Copenhagen, 2100
Denmark
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Bordeaux, 33076
France
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Dijon, 21000
France
Recruiting Study Team BioClin Therapeutics
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Dresden, 01307
Germany
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Frankfurt, 60488
Germany
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Heidelberg, 69120
Germany
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Kassel, 34125
Germany
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Munich, 81377
Germany
Not yet recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Münster, 48149
Germany
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Budapest, 1122
Hungary
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Milano, 20133
Italy
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Milano, 20141
Italy
Recruiting Study Team BioClin Therapeutics

Research Site
Gwangju, 61469
Korea, Republic of
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Seongnam-si, 13620
Korea, Republic of
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Seoul, 03722
Korea, Republic of
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Seoul, 06351
Korea, Republic of
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Utrecht, 3584 CX
Netherlands
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Katowice, 40-514
Poland
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Warsaw, 02-567
Poland
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Warsaw, 02-781
Poland
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Wieliszew, 05-135
Poland
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Wroclaw, 53-413
Poland
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Moscow, 125284
Russian Federation
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.co
Research Site
Saint Petersburg, 197758
Russian Federation
Recruiting Study Team BioClin Therapeutics
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Team
Ufa, 450000
Russian Federation
Recruiting Study Team BioClin Therapeutics
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Belgrade, 11000
Serbia
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Belgrade, 11070
Serbia
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Kragujevac, 34000
Serbia
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Niš, 18000
Serbia
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Sremska Kamenica, 21204
Serbia
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Madrid, CA 28050
Spain
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.co
Research Site
Barcelona, 08035
Spain
Recruiting Study Team BioClin Therapeutics
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Barcelona, 08036
Spain
Recruiting Study Team BioClin Therapeutics
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Madrid, 28034
Spain
Recruiting Study Team BioClin Therapeutics
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Madrid, 28041
Spain
Recruiting BioClin Study Team
+1-925-413-6140
kclin-ops@bioclintherapeutics.com
Research Site
Uppsala, 75185
Sweden
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Ankara, 06100
Turkey
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Antalya, 07059
Turkey
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Dnipropetrovs'k, 49102
Ukraine
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Kiew, 03022
Ukraine
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com