Safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer: a study protocol for a phase 1 multicenter, open-label, single-arm clinical trial
Abstract Background This is a multicenter, open-label, single-arm clinical trial to evaluate the safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer. Methods The trial will be performed at three university hospitals in Japan. The...
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2025-02-01
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| Online Access: | https://doi.org/10.1186/s12885-025-13514-4 |
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| author | Junya Furukawa Yasumasa Kakei Sae Murakami Hiroshi Kita Hideto Ueki Takuto Hara Jun Teishima Nobuyuki Hinata Hideaki Miyake Masato Fujisawa Toshiro Shirakawa |
| author_facet | Junya Furukawa Yasumasa Kakei Sae Murakami Hiroshi Kita Hideto Ueki Takuto Hara Jun Teishima Nobuyuki Hinata Hideaki Miyake Masato Fujisawa Toshiro Shirakawa |
| author_sort | Junya Furukawa |
| collection | DOAJ |
| description | Abstract Background This is a multicenter, open-label, single-arm clinical trial to evaluate the safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer. Methods The trial will be performed at three university hospitals in Japan. The target number of patients will be 12. The patients will be treated orally with B440 once daily for 5 days followed by 2 days for four consecutive courses (4 weeks, 20 treatments). The low-dose group will receive 800 mg (4 capsules) per dose and the high-dose group will receive 1,600 mg (8 capsules) per dose. The primary outcome will be the number and incidence of DLT cases the start of treatment and Day 28. Secondary outcomes are the presence or absence of a response, the best overall response and PFS. Discussion If this trial shows B440 to be safe and effective, it may lead to a late phase randomized controlled trial in advanced urothelial cancer. Ultimately, we hope to provide a new treatment option for such patients. Trial registration Japan Registry of Clinical Trials (jRCT) identifier: jRCT2051220143. Registered on December 27, 2022. |
| format | Article |
| id | doaj-art-ab41698fc7d04d73bef3e15a6a1ff7e5 |
| institution | Kabale University |
| issn | 1471-2407 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj-art-ab41698fc7d04d73bef3e15a6a1ff7e52025-02-09T12:41:36ZengBMCBMC Cancer1471-24072025-02-0125111110.1186/s12885-025-13514-4Safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer: a study protocol for a phase 1 multicenter, open-label, single-arm clinical trialJunya Furukawa0Yasumasa Kakei1Sae Murakami2Hiroshi Kita3Hideto Ueki4Takuto Hara5Jun Teishima6Nobuyuki Hinata7Hideaki Miyake8Masato Fujisawa9Toshiro Shirakawa10Department of Urology, Kobe University Graduate School of MedicineDepartment of Clinical and Translational Research Center, Kobe University HospitalDepartment of Clinical and Translational Research Center, Kobe University HospitalDepartment of Clinical and Translational Research Center, Kobe University HospitalDepartment of Urology, Kobe University Graduate School of MedicineDepartment of Urology, Kobe University Graduate School of MedicineDepartment of Urology, Kobe University Graduate School of MedicineDepartment of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima UniversityDepartment of Urology, Kobe University Graduate School of MedicineDepartment of Urology, Kobe University Graduate School of MedicineDepartment of Urology, Kobe University Graduate School of MedicineAbstract Background This is a multicenter, open-label, single-arm clinical trial to evaluate the safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer. Methods The trial will be performed at three university hospitals in Japan. The target number of patients will be 12. The patients will be treated orally with B440 once daily for 5 days followed by 2 days for four consecutive courses (4 weeks, 20 treatments). The low-dose group will receive 800 mg (4 capsules) per dose and the high-dose group will receive 1,600 mg (8 capsules) per dose. The primary outcome will be the number and incidence of DLT cases the start of treatment and Day 28. Secondary outcomes are the presence or absence of a response, the best overall response and PFS. Discussion If this trial shows B440 to be safe and effective, it may lead to a late phase randomized controlled trial in advanced urothelial cancer. Ultimately, we hope to provide a new treatment option for such patients. Trial registration Japan Registry of Clinical Trials (jRCT) identifier: jRCT2051220143. Registered on December 27, 2022.https://doi.org/10.1186/s12885-025-13514-4B440WT-1 proteinClinical trialadvanced urothelial cancerICIPhase 1 |
| spellingShingle | Junya Furukawa Yasumasa Kakei Sae Murakami Hiroshi Kita Hideto Ueki Takuto Hara Jun Teishima Nobuyuki Hinata Hideaki Miyake Masato Fujisawa Toshiro Shirakawa Safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer: a study protocol for a phase 1 multicenter, open-label, single-arm clinical trial BMC Cancer B440 WT-1 protein Clinical trial advanced urothelial cancer ICI Phase 1 |
| title | Safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer: a study protocol for a phase 1 multicenter, open-label, single-arm clinical trial |
| title_full | Safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer: a study protocol for a phase 1 multicenter, open-label, single-arm clinical trial |
| title_fullStr | Safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer: a study protocol for a phase 1 multicenter, open-label, single-arm clinical trial |
| title_full_unstemmed | Safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer: a study protocol for a phase 1 multicenter, open-label, single-arm clinical trial |
| title_short | Safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer: a study protocol for a phase 1 multicenter, open-label, single-arm clinical trial |
| title_sort | safety and efficacy of oral cancer vaccine b440 in patients with pd 1 pd l1 inhibitor resistant advanced urothelial cancer a study protocol for a phase 1 multicenter open label single arm clinical trial |
| topic | B440 WT-1 protein Clinical trial advanced urothelial cancer ICI Phase 1 |
| url | https://doi.org/10.1186/s12885-025-13514-4 |
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