臨床研究等提出・公開システム

Date of registration	Dec. 27, 2022
Last modified on	Mar. 26, 2026
Trial ID	jRCT2053220142

Scientific Title	A Phase 3, Open Label Trial to Evaluate the Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)
Public Title	Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)

Contact for Scientific Queries	Name	Tantholdt-Hansen Sara
	Affiliation	Ferring Pharmaceuticals A/S
	Address	Amager Strandvej 405 2770 Kastrup Denmark
	Telephone	45-88-33-88-34
	E-mail	JP0-chiken.info@ferring.com
Contact for Public Queries	Name	Saga China
	Affiliation	Ferring Pharmaceuticals Co., Ltd.
	Address	Okura Prestige Tower 10F, 2-10-4 Toranomon, Minato-ku, Tokyo
	Telephone	+81-3-5544-9264
	E-mail	JP0-chiken.info@ferring.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Oct. 23, 2022
Target sample size		24
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	-Have at entry, confirmed by a pathology report: a. Carcinoma in situ (CIS) only b. Ta/T1 high-grade disease with concomitant CIS or c. Ta/T1 high-grade disease without concomitant CIS -Subjects who did not respond to BCG treatment and have a persistent high-grade recurrence within 12 months after BCG was initiated, and those who despite an initial complete response to BCG, relapse with CIS within 12 months of their last intravesical treatment with BCG or relapse with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG. -Life expectancy >2 years, in the opinion of the investigator -Eastern Cooperative Oncology Group (ECOG) status 2 or less -Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra -Subjects with prostate cancer on active surveillance at low risk for progression, defined as prostate-specific antigen (PSA) <10 ng/dL
	Exclusion Criteria	-Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit. -Current systemic therapy for bladder cancer -Current or prior investigational treatment for BCG unresponsive NMIBC or any other investigational drug within 1 month prior to screening -Current or prior pelvic external beam radiotherapy within 5 years of entry -Use of other adenovirus vector medications, including COVID-19 vaccines, within 2 weeks before and after instillation -History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and <=pT2 upper tract urothelial carcinoma at least 24 months after nephroureterectomy. -Subjects who cannot hold instillation for 1 hour -Subjects who cannot tolerate intravesical dosing or intravesical surgical Manipulation -Intravesical therapy within 8 weeks prior to beginning trial treatment, with the exception of: Cytotoxic agents when administered as a single instillation immediately following a TURBT procedure Previous intravesical BCG therapy -Systemic immunosuppressive therapy within 3 months prior to screening
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Bladder Cancer
Intervention(s)		75 mL FE 999326 (3 x 10^11 vp/mL) of sterile suspension instilled once every 3 months into the bladder via a urinary catheter
Primary Outcome(s)		Whether or not a subject with CIS (with or without concomitant high-grade Ta or T1 papillary disease) responds to treatment, defined as complete response at any time after first administration of FE 999326 [Time Frame: At Month 12 assessment]

Primary Sponsor	Ferring Pharmaceuticals Co., Ltd.

Name of Certified Review Board	Nara Medical University Hospital IRB
Address	840 Shijo-cho Kashihara-shi, Nara
Telephone	+81-744-22-3051
E-Mail	chiken-jimunara@naramed-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Kochi Medical School Hospital IRB
Address	185-1 Kohasu,Oko-cho,Nankoku-shi, Nara
Telephone	+81-88-866-5811
E-Mail	im67@kochi-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	St. Marianna University Group IRB
Address	2-16-1 Sugao Miyamae-ku Kawasaki-shi, Nara
Telephone	+81-44-977-8111
E-Mail	chikenjimu@marianna-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	University of Tsukuba Hospital Institutional Review Board
Address	2-1-1 Amakubo Tsukuba-Shi, Nara
Telephone	+81-29-853-3914
E-Mail	chiken@un.tsukuba.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Drug Acceptance Research Review Board of Toyama University Hospital
Address	2630 Sugitani Toyama-shi, Nara
Telephone	+81-76-434-2281
E-Mail	chiken@med.u-toyama.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Okayama University Hospital IRB
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Nara
Telephone	+81-86-235-7534
E-Mail	chiken@okayama-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Juntendo University Hospital Institutional Review Board
Address	3-1-3 Hongo Bunkyo-ku, Nara
Telephone	+81-3-5802-1584
E-Mail	chiken@juntendo.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Institutional Review Board of Osaka Medical and Pharmaceutical University Hospital Clinical Research Center
Address	2-7 Daigaku-machi Takatsuki-shi, Nara
Telephone	+81-72-683-1221
E-Mail	ompu_chiken@ompu.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Hakodate Goryokaku Hospital Insutitutional Review Board
Address	38-3, Goryokakucho, Hakodate-shi, Nara
Telephone	+81-138-51-2295
E-Mail	chiken@gobyou.com
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Institutional Review Board, Mie University Hospital
Address	2-174, Edobashi, Tsu-shi, Nara
Telephone	+81-59-231-5246
E-Mail	chiken-jk@med.mie-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Kyorin University Hospital Institutional review board
Address	6-20-2 Shinkawa, Mitaka-shi, Nara
Telephone	+81-422-47-5511
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Yokohama City University Hospital Institutional Review Board
Address	3-9, Fukuura, Kanazawa-ku, Yokohama-shi, Nara
Telephone	+81-45-787-2714
E-Mail	chiken@yokohama-cu.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Nara
Telephone	+81-3-6665-0572
E-Mail	soudan@hurecs.org
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Toranomon Hospital and Toranomon Hospital Kajigaya Institutional Review Board
Address	2-2-2, Toranomon, Minato-ku, Nara
Telephone	+81-3-3588-1111
E-Mail	chikenjimukyoku@toranomon.gr.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Institute of Science Tokyo Hospital Institutional Review Board
Address	1-5-45, Yushima, Bunkyo-ku, Nara
Telephone	+81-3-5803-5612
E-Mail	tiken.crc@tmd.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Hiroshima University hospital Institutional Review Board
Address	1-2-3, Kasumi, Minami-ku, Hiroshima, Nara
Telephone	+81-82-257-5596
E-Mail	hugcp@hiroshima-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Aichi Medical University Hospital Institutional Review Board
Address	1-1, Yazakokarimata, Nagakute-shi, Nara
Telephone	+81-561-62-3311
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Kyushu University Hospital Institutional Review Board
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Nara
Telephone	+81-92-642-5774
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Wakayama Medical University Insutitutional Review Board
Address	811-1, Kimiidera, Wakayama-City, Nara
Telephone	+81-73-447-2300
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	IRB of Shinshu University Hospital
Address	3-1-1, Asahi, Matsumoto-shi, Nara
Telephone	+81-263-35-4600
E-Mail	chiken@shinshu-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Nagoya University Hospital Institutional review board
Address	65 Tsurumai-cho, Showa-ku, Nagoya-shi, Nara
Telephone	+81-52-741-2111
E-Mail	chiken@med.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	National Hospital Organization Hokkaido Cancer Center Institutional Review Board
Address	3-54, Kikusui 4-2, Shiroishi-ku, Sapporo-shi, Nara
Telephone	+81-11-811-9111
E-Mail	100-mb08chk4@mail.hosp.go.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	National Hospital Organization Shikoku Cancer Center Commissioned Research Review Committee
Address	160 Kou, Minamiumemoto-machi, Matsuyama-shi, Nara
Telephone	+81-89-999-1172
E-Mail	519-tiken@mail.hosp.go.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Japanese Red Cross Narita Hospital Institutional Review Board
Address	90-1, Iida-cho, Narita-shi, Nara
Telephone	+81-476-22-2311
E-Mail	clinical-research@naritasekijyuji.jp
Approval Status	Approval
Date of approval	Nov. 08, 2022

Name of Certified Review Board	Tohoku University Hospital Institutional Review Board
Address	1-1 Seiryo-machi, Aoba-ku, Sendai-shi, Nara
Telephone	+81-22-717-7056
Approval Status	Approval
Date of approval	Nov. 08, 2022

Plan to share IPD	No

Secondary ID(s)	NCT05704244
Issuing Authority	ClinicalTrial.gov

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
11	Mar. 26, 2026	(this page)	Changes
10	Sept. 02, 2025	Detail	Changes
9	Nov. 22, 2024	Detail	Changes
8	Mar. 27, 2024	Detail	Changes
7	Jan. 18, 2024	Detail	Changes
6	Jan. 09, 2024	Detail	Changes
5	Oct. 12, 2023	Detail	Changes
4	Aug. 22, 2023	Detail	Changes
3	May. 20, 2023	Detail	Changes
2	Feb. 12, 2023	Detail	Changes
1	Dec. 27, 2022	Detail

List of change history