7.1.1. Patient Inclusion Criteria

Patients who have signed and dated an approved informed consent form (ICF) and meet all of the

following criteria will be considered eligible for this study:

BCG-Unresponsive Patients (Phase 1 and Phase 2-Cohort 1):

1. BCG-unresponsive NMIBC with Cis of the bladder, with or without coexisting papillary

Ta/T1 tumor(s) who are ineligible for or have elected not to undergo cystectomy, and

have experienced 1) persistent disease within 12 months of treatment or 2) a recurrence

within 6 months of completion of adequate BCG therapy, where:

• Adequate BCG regimen consists of at least 2 courses of BCG where the first course

(induction) must have included at least 5 or 6 doses and the second course may have

included a re-induction (at least 2 of 6 treatments) or maintenance (at least 2 of

3 doses),

• Patients with BCG-unresponsive NMIBC may have received subsequent approved

treatment for NMIBC that discontinued no more than 4 months of Screening, and

• Cis must be documented or indicated by pathology at Screening or within 4 months of

Screening (provided no therapy for Cis disease was given after the most

recent biopsy).

BCG-Naïve or BCG-Incompletely Treated Patients (Phase 2-Cohort 2 Only):

1. NMIBC with current Cis of the bladder, with or without coexisting papillary Ta/T1

NMIBC tumor(s), who are ineligible for or have elected not to undergo

cystectomy where:

• Either: a) incomplete BCG (at least 1 dose) treatment or b) no treatment with BCG

due to unavailability, but who have previously been treated with at least 1 dose of

intravesical chemotherapy following transurethral resection of bladder

tumor (TURBT), and

• Cis must be documented or indicated by pathology within 4 months of or at Screening

(without Cis treatment).

All Patients (Note if criterion specifies Phase 1 or 2 and Cohort):

1. Patients who have previously been treated with an investigational or approved checkpoint

inhibitor (e.g., pembrolizumab) are eligible for inclusion 30 days post-treatment (Phase 1)

or 3 months post-treatment (Phase 2).

1. Male or non-pregnant, non-lactating female, 18 years or older.
2. Women of child-bearing potential must have a negative pregnancy test at Screening. A

female patient is considered to be of child-bearing potential unless she:

• has had a hysterectomy or bilateral oophorectomy, or
• is age greater than or equal than 60 years and is amenorrhoeic, or
• is age less than or equal than 60 years and has been amenorrhoeic for ≥ 12 months (including no irregular

menses or spotting) in the absence of any medication which induces a menopausal

state and has documented ovarian failure by serum oestradiol and follicle-stimulating

hormone levels within the postmenopausal range).

1. Female patients of child-bearing potential must be willing to consent to using effective

double-barrier contraception, i.e., intrauterine device, birth control pills, depo-provera,

and condoms while on treatment and for 3 months after their participation in the study

ends; Male patients are required to utilize a condom for the duration of the study

treatment through 3 months post-dose.

1. In Phase 2, for patients with T1 lesions, Screening biopsy must be considered adequate

(contain the muscularis layer).

1. Performance Status: Eastern Cooperative Oncology Group 0, 1, and 2.
2. Hematologic inclusion at Screening: .
3. Hepatic inclusion at Screening:

• Total bilirubin must be ≤1.5 x the upper limit of normal (ULN).
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN,

and alkaline phosphatase ≤2.5 x ULN.

1. Adequate renal function with creatinine clearance >30 mL/min.
2. Prothrombin time and partial thromboplastin titime 1.25 x ULN at Screening or within

the therapeutic range if on anticoagulation therapy.

1. Must have satisfactory bladder function with abilit