Ph I/II EG-70 Intravesical Admin w/BCG-Unresponsive NMIBC &BCG Naïve Received Incomplete BCG Tx
Study Description
EG-70 is a nanoparticle containing the pDNA drug substance (N9-h12-R) packaged in a modified chitosan-based polymer called RXG and further combined with a PEG-b-PLE diblock copolymer. RXG and PEG-b-PLE are both novel excipients. The product is formulated as an aqueous nanoparticle dispersion in mannitol solution, filter sterilized andlyophilized to a dry powder.
The specific properties and ratios of the pDNA, RXG, PEG-b-PLE, and mannitol excipients were chosen as a result of screening experiments focused on physiochemical characteristics, stability, and biological potency in a mouse model. Each single-dose vial of the drug product will be rehydrated with sterile water for injection (sWFI) or sterile water for irrigation at the clinical site prior to administration to the patient via intra-urethral catheter delivery.
Eligibility
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):
- 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):
- 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):
- 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).
- Male or non-pregnant, non-lactating female, 18 years or older.
- 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).
- 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.
- In Phase 2, for patients with T1 lesions, Screening biopsy must be considered adequate
(contain the muscularis layer).
- Performance Status: Eastern Cooperative Oncology Group 0, 1, and 2.
- Hematologic inclusion at Screening: .
- 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.
- Adequate renal function with creatinine clearance >30 mL/min.
- Prothrombin time and partial thromboplastin titime 1.25 x ULN at Screening or within
the therapeutic range if on anticoagulation therapy.
- Must have satisfactory bladder function with abilit
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