The safety and efficacy of oral cancer vaccine B440

Phase 1

Recruiting

Conditions: Advanced urothelial carcinoma
D002295

Registration Number: JPRN-jRCT2051220143

Lead Sponsor: Teishima Jun

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 12

Inclusion Criteria

1. Be willing and able to provide written informed consent for the adequate explanation of this trial.
2. Age between 18 and 85 at the time of informed consent.
3. Have histologically confirmed urothelial carcinoma.
4. Have urothelial carcinoma resistant or intolerant to PD-1/PD-L1 inhibitors.
5. Have unresectable urothelial carcinoma refractory or intolerant to standard treatment (including Enfortumab vedotin).
6. General condition is 0 or 1 in Performance Status (PS) based on ECOG (Eastern Cooperative Oncology Group).
7. Have at least 1 measurable lesion (including lymph node lesion) based on RECIST (Response Evaluation Criteria in Solid Tumors) ver1.1 that has not been irradiated.
8. The test value within 14 days before registration satisfies all the following test criteria. In addition, it is conditional that the blood transfusion has not been performed within 14 days (including same day of the week) before the examination.
a. Neutrophil count 1.5 x10^3/microL or more
b. Hemoglobin 8.0g/dL or more
c. Platelet count 75 x10^3/microL or more
d. Total bilirubin 1.5mg/dL or less
e. AST (GOT) 100 U/L or less, ALT (GPT) 100 U/L or less
f. Serum creatinine 1.5mg/dL or less, or calculated creatinine clearance (Cockcroft-Gault formula) 50mL/min or more
g. SpO2 93 percent or more
9. Adverse events associated with prior treatment have resolved to Grade 1 or less in CTCAE (Common Terminology Criteria for Adverse Events) v5.0-JCOG (Japan Clinical Oncology Group); or Grade 2 or higher symptoms (hair loss, peripheral sensory neuropathy, skin hyperpigmentation, dysgeusia) are stable.

Exclusion Criteria

1. Has been administered anticancer drugs and other therapeutic drugs within 28 days before registration.
2. Has an infection requiring systemic treatment.
3. Has serious complications (intestinal paralysis, intestinal obstruction, pulmonary fibrosis, uncontrolled diabetes, heart failure, myocardial infarction, angina pectoris, renal failure, liver failure, psychiatric disease, cerebrovascular disease, ulcer required transfusion, etc.).
4. Has history or complication of interstitial pneumonia requiring treatment.
5. Has severe mental disorder.
6. Pregnant, possibly pregnant diagnosed by doctor interview etc, or breast-feeding* (* Breast-feeding who discontinue breastfeeding will not be enrolled in this study)
7. There is no intention of contraception in the subject or his/her partner from the start of administration of B440 to the specified period* (* Male: a period from the start of the drug administration to 180 days after the last dose of the drug, Female who may become pregnant: a period from the start of the drug administration to 154 days after the last dose of the drug).
8. A subject of childbearing potential who is unable to perform a pregnancy test at screening.
9. Has a history of severe drug allergy.
10. Positive for either HBs antigen or HCV antibody in a test within 6 months before the enrollment.
11. Positive for HIV antibody in past tests.
12. Be receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive agents (except for immune-related adverse events caused by immune checkpoint inhibitors).
13. Has complication of autoimmune disease or history of chronic or recurrent autoimmune disease (except immune-related adverse events caused by immune checkpoint inhibitors).
14. Has a history of hypersensitivity to the ingredients of this drug and bifidobacteria protein.
15. Be judged by the investigator or subinvestigator to be inappropriate to participate in this study.