Phase 1/2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer

Status: Recruiting
Location: See all (60) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D. Part 4 (RP2D expansion) will assess the overall complete response (CR) in participants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; means the cancer cells are only in the bladder's inner lining).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Parts 1-3:

• Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder

• For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to the start of study treatment. Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests

• Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable. Participants who received an abbreviated course of BCG due to toxicity are still eligible

• Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)

• Cohorts 2 and 4: Willing and eligible for RC

⁃ Part 4:

• Have histologically confirmed diagnosis of recurrent Intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC) Ta LG tumors

• Must not have undergone tumor debulking or selective ablation of visible lesions; partial tumor biopsy to confirm diagnosis and provide tissue for biomarker testing is permitted as long as remaining tumor is at least 5 millimeter (mm) in size

• Must submit tissue and urine for FGFR testing

• Can have a prior or concurrent second malignancy which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment

Locations
United States
Alabama
University of Alabama at Birmingham - The Kirklin Clinic
RECRUITING
Birmingham
California
University of Southern California
RECRUITING
Los Angeles
Colorado
Urology Associates of Denver
RECRUITING
Lone Tree
Florida
Urological Research Network
RECRUITING
Hialeah
Advanced Urology Institute
RECRUITING
Largo
Advent Health Orlando
RECRUITING
Orlando
Advanced Urology Institute
COMPLETED
Oxford
H Lee Moffitt Cancer Center
RECRUITING
Tampa
Illinois
Northwestern University
RECRUITING
Chicago
Associated Urological Specialists
RECRUITING
Chicago Ridge
Indiana
Urology of Indiana
RECRUITING
Greenwood
Urologic Specialists of Northwest Indiana
RECRUITING
Merrillville
Kentucky
University of Kentucky
RECRUITING
Lexington
Louisiana
Southern Urology LLC
RECRUITING
Lafayette
Massachusetts
Greater Boston Urology
RECRUITING
Plymouth
Missouri
Specialty Clinical Research of St Louis
RECRUITING
St Louis
North Carolina
Levine Cancer Institute, Carolinas HealthCare System
COMPLETED
Charlotte
New Jersey
Hackensack University Medical Center Urology
RECRUITING
Hackensack
New York
Associated Medical Professionals
RECRUITING
Syracuse
Ohio
Central Ohio Urology Group
RECRUITING
Gahanna
South Carolina
Carolina Urologic Research Center
RECRUITING
Myrtle Beach
Low Country Urology Clinics
RECRUITING
North Charleston
Tennessee
Urology Associates
RECRUITING
Nashville
Texas
Urology Austin
RECRUITING
Austin
Urology San Antonio Research
RECRUITING
San Antonio
Other Locations
Canada
Nova Scotia Health Authority
RECRUITING
Halifax
St Josephs Healthcare Hamilton
RECRUITING
Hamilton
Princess Margaret Cancer Centre
RECRUITING
Toronto
Vancouver Prostate Centre Diamond Health Care Centre
RECRUITING
Vancouver
Germany
Universitatsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Urologicum Duisburg
RECRUITING
Duisburg
Universitatsklinikum Frankfurt
RECRUITING
Frankfurt Am Main
Universitatsklinikum Freiburg
TERMINATED
Freiburg Im Breisgau
Marien hospital Herne
RECRUITING
Herne
Urologie Neandertal Praxis Mettmann
RECRUITING
Mettmann
Universitatsklinikum Munster
RECRUITING
Münster
Universitaetsklinikum Ulm
RECRUITING
Ulm
Israel
Carmel Medical Center
RECRUITING
Haifa
Rambam Medical Center
RECRUITING
Haifa
Rabin Medical Center
RECRUITING
Petah Tikva
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Japan
National Hospital Organization Kyushu Medical Center
RECRUITING
Fukuoka
Yamanashi Prefectural Central Hospital
RECRUITING
Kofu
Osaka General Medical Center
RECRUITING
Osaka
Toyama University Hospital
RECRUITING
Toyama
Netherlands
Radboud Umcn
COMPLETED
Nijmegen
UMC Utrecht
COMPLETED
Utrecht
Republic of Korea
National Cancer Center
RECRUITING
Goyang-si
Chonnam National University Hospital
RECRUITING
Gwangju
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea Seoul St Marys Hospital
RECRUITING
Seoul
Spain
Fund. Puigvert
COMPLETED
Barcelona
Hosp Clinic de Barcelona
RECRUITING
Barcelona
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Hosp Reina Sofia
RECRUITING
Córdoba
Hosp Univ Fund Jimenez Diaz
RECRUITING
Madrid
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hosp. Univ. La Paz
RECRUITING
Madrid
Instituto Valenciano de Oncologia
RECRUITING
Valencia
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2022-04-11
Estimated Completion Date: 2029-10-01
Participants
Target number of participants: 262
Treatments
Experimental: Part 1: Dose Escalation
Participants with recurrent, bacillus Calmette-Guerin (BCG)-experienced high risk papillary-only Non-Muscle-Invasive Bladder Cancer (NMIBC), refusing or ineligible for radical cystectomy or with recurrent, intermediate-risk NMIBC will receive Erdafitinib Intravesical Delivery System. The dose will be escalated to determine preliminary recommended phase 2 dose(s) (RP2D\[s\]) for Part 2.
Experimental: Part 2: Dose Expansion
Participants in each of 5 disease-specific NMIBC or MIBC cohorts may be enrolled at one or more dose levels that have been determined to be safe in Part 1.
Experimental: Part 3: RP2D Dose Expansion
Participants in 2 of the disease-specific NMIBC cohorts (cohorts 1 and 3) may be enrolled at RP2D to determine the safety, evaluate PK and preliminary clinical activity.
Experimental: Part 4: Phase 2 Expansion
Participants with recurrent IR-NMIBC will be enrolled in this part to further evaluate the safety, efficacy, and PK of the selected RP2D.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov

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