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A clinical trial of HM-001 in patients with non-muscle invasive bladder cancer receiving TURBT therapy: Phase I/IIa, open-label, investigator-initiated study

HM-001-CT1 Study

Kawashima Atsunari

Osaka University Hospital

2-15 Yamadaoka, Suita, Osaka

hm-001-toiawase@dmi.med.osaka-u.ac.jp

Harada Hideaki

Osaka University Hospital

2-2 Yamadaoka, Suita, Osaka

+81-6-6210-8289

hm-001-toiawase@dmi.med.osaka-u.ac.jp

Recruiting

June. 21, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Clinically diagnosed non-muscle invasive bladder cancer by cytology or cystoscopy.
2) TURBT is scheduled.
3) Any of the following, and none of the standard intravesical drug therapy after TURBT is judged to be an indication.
(1) Refractory or intolerant to intravesical instillation of at least one antineoplastic agent
(2) Refractory or intolerant to intravesical BCG therapy
(3) A first case but refusing intravesical instillation of antineoplastic agent
(4) A first case but refuses intravesical BCG therapy
4) Total cystectomy is not indicated.
5) Age 20 years or older at the time of informed consent.
6) Patients with ECOG PS 0, 1 or 2.
7) Prognosis can be expected for more than 1 year.
8) Written informed consent has been obtained from the patient to be a subject of this study.

1) Patients with non-muscle invasive bladder cancer (NMIBC) but with carcinoma in situ of the bladder (CIS).
2) Active multiple cancers (simultaneous multiple cancers and ectopic multiple cancers with disease-free interval within 5 years). However, carcinoma in situ or lesions equivalent to intramucosal carcinoma that are judged to be cured by local therapy are not included in active multiple cancers.
3) Requires continuous systemic administration (oral or intravenous) of steroids or immunosuppressants. However, topical treatments such as topical steroids and inhaled steroids are not covered.
4) Have a history of treatment with other investigational drugs or unapproved drugs within 28 days before obtaining informed consent.
5) Serious complications (severe congestive heart failure, renal failure, liver failure, uncontrolled diabetes, uncontrolled hypertension, etc.).
6) Active infection requiring systemic treatment.
7) Positive for any infectious disease screening (HIV, HBV, HCV*1, HTLV-1, syphilis).
*1: Even if HCV antibody is positive, patients in whom HCV-RNA is not detected are not excluded.
8) Have a mental disorder that seems to affect the continuation of the study.
9) Abnormal values of renal function, liver function and bone marrow function at screening test as follows.
(1) White blood cell count: less than 3000/microliter
(2) Neutrophil count: less than 1500/microliter
(3) Hemoglobin: less than 10.0 g/dL
(4) Platelets: less than 100,000/microliter
(5) Total bilirubin: 1.5 mg/dL or more
(6) Either AST or ALT: 100 U/L or more
(7) eGFR: less than 30 mL/min/1.73m2
10) Difficulty in contraception from the start of study drug administration to the end of follow-up observation.
11) Pregnant women, women who are breast-feeding, who are determined to be pregnant based on an interview with a doctor. Even if the subject is breast-feeding, it is not excluded if breast-feeding can be interrupted from the start of study drug administration to the end of follow-up observation.
12) Patients who are judged to be unsuitable for the safe conduct of this study by investigators.

Both

Non-muscle invasive bladder cancer

Part 1:
A single intravesical dose of sodium chlorite 24 mg/30 mL, 48 mg/30 mL, or 96 mg/30 mL immediately after surgery (Week 1 Day 1) for patients with non-muscle invasive bladder cancer who received TURBT therapy.
Then repeat intravesical instillation once a week (Day 1 of each week) from Week5 to Week10 for 6 times with the same dose.
After intravesical instillation of sodium chlorite, as a general rule, it should be held for at least 1 hour before excretion. Even if it is necessary to shorten the holding time due to the subject's general condition, hold it for at least 30 minutes.

part 2:
<Induction administration period>
A single intravesical instillation of sodium chlorite at the dose estimated to be recommended dose in Part 1 immediately after surgery (Week 1 Day 1) for patients with non-muscle invasive bladder cancer who received TURBT therapy.
Thereafter, intravesical instillation of the same dose once a week from Week 5 to Week 10 (Day 1 of each Week).
After intravesical instillation of sodium chlorite, as a general rule, it should be held for at least 1 hour before excretion. Even if it is necessary to shorten the holding time due to the subject's general condition, hold it for at least 30 minutes.
<Maintenance administration period>
Subjects who have completed the induction administration period are given the same dosage as the induction administration period, and from Week 18 Day 1, intravesical instillation is repeated once a week for 3 consecutive weeks, 3 times at 13-week intervals. That is, intravesical instillation is performed on Day 1 of Week 18, 19, 20, 31, 32, 33, 44, 45, and 46.
After intravesical instillation of sodium chlorite, as a general rule, it should be held for at least 1 hour before excretion. Even if it is necessary to shorten the holding time due to the subject's general condition, hold it for at least 30 minutes.

Part 1: Presence or absence of dose limiting toxicity (DLT)

Part 2: Bladder cancer non-recurrence rate up to last observation

+81-6-6210-8290

Mar. 14, 2023

No

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