Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
BCG-unresponsive Patients:
1. BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without resected papillary
tumors who are ineligible for or have elected not to undergo cystectomy:
- persistent high-grade disease (Ta, T1, or Tis) after receiving intravesical BCG
induction (at least 5 of 6 induction doses) plus maintenance (at least 2 of 3
doses) or recurrence of high-grade papillary disease within 6 months or Tis
within 12 months of BCG instillation or
- T1 high grade disease residual at the first evaluation following induction BCG
(at least 5 of 6 doses).
BCG-Naïve or BCG-incompletely treated Patients (Phase 2 Only):
2. NMIBC with Cis with or without resected papillary tumors who are ineligible for or
have elected not to undergo cystectomy:
- persistent high-grade disease (Ta, T1, or Tis):
- after incomplete BCG treatment (at least 1 dose) or
- who have not yet received any treatment with BCG, but who have previously been
treated with at least 1 dose of intravesical chemotherapy following transurethral
resection of bladder tumor (TURBT)
All Patients:
3. Patients who have previously been treated with an investigational or approved
checkpoint inhibitor (e.g., pembrolizumab) and failed treatment are eligible for
inclusion 30 days post-treatment (Phase 1) or 3 months post-treatment (Phase 2).
4. Male or non-pregnant, non-lactating female, 18 years or older.
5. Women of childbearing potential must have a negative pregnancy test at Screening. A
female patient is considered to be of child-producing potential unless she:
1. has had a hysterectomy or bilateral oophorectomy or
2. is age ≥ 60 years and is amenorrhoeic or
3. is age < 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 institutional laboratory
postmenopausal range).
6. All patients of childbearing 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.
7. In Phase 2, for patients with T1 lesions, Screening biopsy must be considered adequate
(contain the muscularis layer).
8. Performance Status: Eastern Cooperative Oncology Group (ECOG) 0, 1, and 2.
9. Hematologic inclusion within 2 weeks of start of treatment:
1. Absolute neutrophil count >1,500/mm3.
2. Hemoglobin >9.0 g/dl.
3. Platelet count >100,000/mm3.
10. Hepatic inclusion within 2 weeks of Day 1:
1. Total bilirubin must be ≤1.5 x the upper limit of normal (ULN).
2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN
for the institution, alkaline phosphatase ≤2.5 x ULN for the institution, unless
bone metastasis is present in the absence of liver metastasis.
11. Adequate renal function with creatinine clearance >30 mL/min
12. Prothrombin time and partial thromboplastin time within the normal limits at
Screening.
13. Must have satisfactory bladder function with ability to retain study drug for a
minimum of 60 minutes.
14. Patient or legally authorized representative (LAR) must be willing and able to comply
with all protocol requirements.
15. Patient or LAR must be willing and able to give informed consent and any
authorizations required by local law for participation in the study.
Exclusion Criteria:
1. Any other malignancy diagnosed within 1 year of study entry (except basal or squamous
cell skin cancers or noninvasive cancer of the cervix) is excluded.
2. Concurrent treatment with any chemotherapeutic agent.
3. History of partial cystectomy.
4. Treatment with pembrolizumab within 30 days (Phase 1) or 3 months (Phase 2) prior to
Screening.
5. Treatment with last therapeutic agent (including intravesical chemotherapy post-TURBT)
within 30 days of Screening (Phase 1 and Phase 2) or treatment with an investigational
checkpoint inhibitor within 3 months of Screening (Phase 2 only).
6. Evidence of persistent or ongoing renal failure.
7. History of unresolved vesicoureteral reflux or an indwelling urinary stent.
8. History of unresolved hydronephrosis due to ureteral obstruction.
9. Participation in any other research protocol involving administration of an
investigational agent within 1 month prior to Day 1.
10. History of external beam radiation to the pelvis at any time or prostate brachytherapy
within the last 12 months.
11. History of interstitial lung disease and/or pneumonitis in patients who have
previously received a PD-1 or PD-L1 inhibitor therapy.
12. Evidence of metastatic disease.
13. History of difficult catheterization that in the opinion of the Investigator will
prevent administration of EG-70.
14. History of interstitial cystitis.
15. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic
therapy.
16. Known human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection.
17. Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial
infarction within 6 months).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 12/22/23. Questions regarding updates should be directed to the study team contact.