EG-70 in NMIBC Patients Who Are BCG-Unresponsive and High-Risk NMIBC Patients Who Have Been Incompletely Treated With BCG or Are BCG-Naïve (LEGEND STUDY)

  • STATUS
    Recruiting
  • End date
    Feb 23, 2026
  • participants needed
    222
  • sponsor
    enGene, Inc.
Updated on 23 May 2022

Summary

This open-label, multicenter study will evaluate the safety and efficacy of intravesical administration of EG-70 and its effect on bladder tumors in patients with NMIBC who have failed BCG therapy and are recommended for radical cystectomy or high-risk NMIBC patients who are BCG-naïve or have received incomplete BCG treatment. This study study consists of two phases, a dose-escalation Phase (Phase 1) to establish safety and recommended phase 2 dose (RP2D), followed by a Phase 2 efficacy study at the RP2D to establish efficacy. Eligible BCG-unresponsive NMIBC patients will be enrolled in Phase 1, and Cohort 1 of Phase 2. Eligible high-risk NMIBC patients who have been incompletely treated or are BCG-naïve will be enrolled starting in Phase 2 in a separate single-arm cohort (Cohort 2).

Description

EG-70 is a novel non-viral gene therapy. EG-70 is designed to elicit a local immune response following delivery of gene therapies to mucosal tissues, such as the bladder urothelium. This approach of local administration through bladder instillation has the potential to induce a potent immune response exclusively at the site of the tumor, resulting in greater therapeutic benefit while reducing undesirable systemic toxicity.

Details
Condition Superficial Bladder Cancer
Treatment EG-70
Clinical Study IdentifierNCT04752722
SponsorenGene, Inc.
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without resected papillary tumors who are indicated for, ineligible for, or have elected not to undergo
BCG-unresponsive Patients
cystectomy
T1 high grade disease residual at the first evaluation following induction BCG (at least 5 of 6 doses)
persistent high-grade disease (Ta, T1, or Tis) after receiving at least one induction course of intravesical BCG (at least 5 of 6 induction doses) or recurrence after 12 months of receiving at least one induction course of intravesical BCG (at least 5 of 6 induction doses), or
BCG-Naïve or BCG-incompletely treated Patients (Phase 2 Only)
NMIBC with CIS with or without resected papillary tumors who are indicated for
has had a hysterectomy or bilateral oophorectomy or
ineligible for, or have elected not to undergo cystectomy
persistent high-grade disease (Ta, T1, or Tis) or recurrence within 6 months of
receiving at least 1 dose, but not the full course, of intravesical BCG, or
high-grade disease (Ta, T1, or Tis) who have not yet received any treatment with
Performance Status: Eastern Cooperative Oncology Group (ECOG) 0, 1, and 2
BCG, or
Hematologic inclusion within 2 weeks of start of treatment
All Patients
T1 high grade disease residual at the first evaluation following incomplete
Absolute neutrophil count >1,500/mm3
treatment with BCG
Hemoglobin >9.0 g/dl
Patients who have previously been treated with at least one dose of intravesical
Platelet count >100,000/mm3
chemotherapy at TURBT are eligible for inclusion one month post-treatment
Hepatic inclusion within 2 weeks of Day 1
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)
Male or non-pregnant, non-lactating female, 18 years or older
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
is age ≥ 60 years and is amenorrhoeic or
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)
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
Total bilirubin must be ≤1.5 x the upper limit of normal (ULN)
Adequate renal function with creatinine clearance >30 mL/min (measured using
Cockcroft-Gault equation or the estimated glomerular filtration rate from the
Modification of Diet in Renal Disease Study)
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
Prothrombin time and partial thromboplastin time within the normal limits at
Screening
Must have satisfactory bladder function with ability to retain study drug for a
minimum of 60 minutes
Patient or legally authorized representative (LAR) must be willing and able to comply
with all protocol requirements
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

Concurrent treatment with any chemotherapeutic agent
Treatment with last therapeutic agent within 30 days of Screening (Phase 1 and Phase
History of vesicoureteral reflux or an indwelling urinary stent
Evidence of metastatic disease
History of interstitial cystitis
Known human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection
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
Treatment with pembrolizumab within 30 days (Phase 1) or 3 months (Phase 2) prior to
Screening
) or treatment with an investigational checkpoint inhibitor within 3 months of
Screening (Phase 2 only)
Participation in any other research protocol involving administration of an
investigational agent within 1 month prior to Day 1
History of external beam radiation to the pelvis at any time or prostate brachytherapy
within the last 12 months
History of interstitial lung disease and/or pneumonitis in patients who have
previously received a PD-1 or PD-L1 inhibitor therapy
History of difficult catheterization that in the opinion of the Investigator will
prevent administration of EG-70
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic
therapy
Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial
infarction within 6 months)
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