Table 1 Inclusion and exclusion criteria

Subjects fulfilling all of the following inclusion criteria are eligible for the study:

1

Informed consent as documented by signature

2

Age ≥ 18 years

3

ECOG performance status of 0 or 1

4

Histologically confirmed intermediate-risk non-muscle invasive urothelial carcinoma of the bladder (pTa low grade)

5

Representative fresh tumor specimen for PDO generation and drug screen available.The presence of representative fresh tumor tissue will be confirmed as a re-assessment of eligibility at time point of surgery (Visit 2)

The presence of any one of the following exclusion criteria will lead to exclusion of the subject:

1

Known previous high grade and/or high-risk non-muscle invasive bladder cancer

2

Previous intravesical biological/immune- (BCG) therapy

3

Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol as judged by the investigator

4

Severe infection within 4 weeks prior to cycle 1, day 1

5

Contraindication for frequent catheterization

6

Voiding dysfunction

7

Pregnancy or nursing

8

Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 6 months after the last treatment. Note: Women not of childbearing potential are defined as:

postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.) OR have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; OR has a congenital or acquired condition that prevents childbearing

9

Male subject who is unwilling to use acceptable method of effective contraception during IMP treatment and through 6 months after the last dose of IMP. For this trial, male subjects will be considered to be of non-reproductive potential if they have azoospermia (whether due to having had a vasectomy or due to an underlying medical condition)