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BRIEF TITLE: 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

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


  • Org Study ID: B-701-U21
  • Secondary ID: 2017-001319-36
  • NCT ID: NCT02401542
  • NCT Alias:
  • Sponsor: BioClin Therapeutics, Inc. - Industry
  • Source: BioClin Therapeutics, Inc.

Brief Summary

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).

Detailed 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. Vofatamab is a novel monoclonal antibody specific for fibroblast growth factor
receptor 3 (FGFR3) that is being developed to target FGFR3-positive tumors.

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).

Overal Status Start Date Phase Study Type
Recruiting Start Date: June 2015 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Primary Efficacy Outcome: Progression Free Survival (PFS)

Primary Outcome 1 - Time Frame: 3-4 years

Condition:

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

Eligibility

Criteria:
Key Disease Specific Inclusion 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)

Phase 2 and Phase 2b Specific Inclusion Criteria:

1. Patient must be confirmed to have a FGFR3 genomic alteration at the time of
documentation of advanced disease.

2. Relapsed after or are refractory to an immune checkpoint inhibitor. This inclusion
criterion does not apply if the checkpoint inhibitor is contraindicated.

Main Exclusion Criteria:

- Prior anti-cancer therapy within 2 weeks prior to Cycle 1, Day 1

- Prior treatment with an inhibitor that is targeted primarily to FGFRs

- Clinically significant comorbid medical conditions or lab abnormalities

- History of major bleeding (requiring a blood transfusion ≥ 2 units) not related to a
tumor within the past 12 months

- History of clinically significant coagulation or platelet disorder in the past 12
months

- Currently receiving anticoagulation treatment

- Incomplete healing from wounds from prior surgery

- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at
screening

- Presence of positive test results for Hepatitis B or Hepatitis C

- Known history of human immunodeficiency virus (HIV) seropositive status
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
Gilbert, Arizona 85234
United States
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Goodyear, Arizona 85338
United States
Recruiting BioClin Study Team

Clin-ops@bioclintherapeutics.com
Research Site
Duarte, California 91010
United States
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
San Francisco, California 94115
United States
Withdrawn
Research Site
Miami, Florida 33140
United States
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Reaserach Site
Fort Wayne, Indiana 46845
United States
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Louisville, Kentucky 40202
United States
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Boston, Massachusetts 02215
United States
Terminated
Research Site
Detroit, Michigan 48201
United States
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Rochester, Minnesota 55905
United States
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Syracuse, New York 13210
United States
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Canton, Ohio 44718
United States
Withdrawn
Research Site
Dallas, Texas 75390-9110
United States
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Olomouc, 77900
Czechia
Recruiting BioClin Study Team

Research Site
Prague, 12808
Czechia
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Ancona, 60126
Italy
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Catania, 95123
Italy
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Milan, 20132
Italy
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Milan, 20133
Italy
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Milan, 20141
Italy
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Modena, 41124
Italy
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Napoli, 80131
Italy
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Negrar, 37024
Italy
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Siena, 53100
Italy
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Gwangju, 61469
Korea, Republic of
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Incheon, 405-760
Korea, Republic of
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Seongnam-si, 13620
Korea, Republic of
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Seoul, 02841
Korea, Republic of
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Seoul, 03080
Korea, Republic of
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Seoul, 03722
Korea, Republic of
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Seoul, 05505
Korea, Republic of
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Seoul, 06351
Korea, Republic of
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Badalona, 08916
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Barcelona, 08003
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Barcelona, 08026
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Barcelona, 08036
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Barcelona, 08908
Spain
Recruiting BioClin Study Team
+1-925-413-6140
clin-ops@bioclintherapeutics.com
Research Site
Granada, 18014
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Lugo, 27003
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Madrid, 28007
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Madrid, 28033
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Madrid, 28041
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Madrid, 28046
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Madrid, 28050
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Oviedo, 33011
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Pamplona, 31008
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Valencia, 46009
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Vigo, 36204
Spain
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Uppsala, 751 85
Sweden
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Kaohsiung, 81362
Taiwan
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Kaohsiung, 83301
Taiwan
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Taichung, 40447
Taiwan
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Taichung, 435
Taiwan
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Tainan, 704
Taiwan
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Taipei, 110
Taiwan
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Taipei, 11217
Taiwan
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Taoyuan, 333
Taiwan
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Adana, 01330
Turkey
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Ankara, 06590
Turkey
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Antalya, 07059
Turkey
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Bursa, 16059
Turkey
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Edirne, 22030
Turkey
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
İstanbul, 34732
Turkey
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
İzmir, 35340
Turkey
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Malatya, 44280
Turkey
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
London, SW36JJ
United Kingdom
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com
Research Site
Preston, PR29HT
United Kingdom
Recruiting BioClin Study Team

clin-ops@bioclintherapeutics.com