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(a) Age at least 18 years.
(b) Histologically confirmed diagnosis of urothelial carcinoma of the urinary bladder stage Ta or T1 with low histological grade.
(c) Performance status: ECOG 0-1
(d) Subjects who have read and understood the informed consent form and are willing and able to give informed consent. Subjects who fully understand the requirements of the trial and are willing to comply with all trial visits and assessments.
(e) Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For the purposes of this trial, 'women of childbearing potential' is defined as: *All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive*.
(f) Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to, during and four weeks after the last dose trial medication. 'Adequate contraception' is defined as follows: two barrier methods, or one barrier method with a spermicide or intrauterine device.
Patients to enter the first part of the study:
(g) Complete removal of tumours through TUR procedure
Patients to enter the second part of the study:
(h) Prior to TUR multiple tumours but not more than seven.
(i) One marker lesion left for assessment after TUR procedure, between 0.5 to 1.0 cm in diameter, documented with video or photo.

Exclusion Criteria

(a) Previous or current history of urinary tract high grade tumour, carcinoma in situ, muscle invasive disease (stage T2 or higher).
(b) Any prior intravesical BCG or any other immunotherapy within the last 24 months.
(c) Previous intravesical treatment with chemotherapy agents within 6 months of entry into the study.
(d) Subjects who cannot hold instillation for at least one hour.
(e) Subjects who cannot tolerate intravesical administration or intravesical surgical manipulation.
(f) Current or prior pelvic external beam radiation or pelvic brachytherapy.
(g) Existing urinary tract infections or recurrent severe bacterial cystitis.
(h) History of disease of the upper urinary tracts (e.g. vesico-urethral reflux, indwelling urinary stent, UT stones).
(i) High grade urinary cytology.
(j) Bone marrow impairment as evidenced by Haemoglobin < 9.0 g/dL, ANC 1.5 x 109/L, platelets < 120 x 109/L
(k) Renal impairment as evidenced by serum creatinine > 1.5 x ULN, and/or calculated creatinine clearance < 60 mL/min.
(l) Liver function abnormality as defined by total bilirubin > 1.5 x ULN, or AST/ALT > 2.5 x ULN.
(m) Bleeding disorders as evidenced by INR > 1.5 x ULN.
(n) Immunosuppressed patients or patients receiving immunosuppressive therapy or who are otherwise immunocompromised.
(o) Known HIV positivity, active hepatitis C, or active hepatitis B.
(p) Any other active malignancy except study indication and basal or squamous cell skin cancers.
(q) Clinically significant active infections within 4 weeks before initial treatment administration.
(r) Any medical or psychiatric condition which, in the opinion of the investigator, might impair the subject*s well being or preclude him from adhering to the protocol or completing the trial as per protocol.
(s) Suspected hypersensitivity to imidazoquinoline compounds, poloxamer 407, hydroxy propyl betacyclodextrin, lactic acid.
(t) Women who are pregnant or breast feeding.
(u) Participation in any other protocol involving administration of an investigational agent within 3 months prior to entering this study.