LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve

STATUS

Recruiting
End date

May 15, 2027
participants needed

222
sponsor

enGene, Inc.

Updated on 15 September 2023

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Summary

This study will evaluate the safety and efficacy of intravesical administration of EG-70 and in the bladder and its effect on bladder tumors in patients with NMIBC.

This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is.

The Study will include patients with NMIBC for whom BCG therapy is unresponsive and are recommended for radical cystectomy, or high-risk NMIBC patients who are BCG-naïve or have received incomplete BCG treatment.

Description

EG-70 is a novel non-viral gene therapy. EG-70 is designed to elicit a local immune response following delivery of the study gene therapy to 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.

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).

Patients will be treated for up to four 12-week cycles of study drug instillation doses and assessments with follow up assessments.

Details

Condition	Superficial Bladder Cancer
Treatment	EG-70
Clinical Study Identifier	NCT04752722
Sponsor	enGene, Inc.
Last Modified on	15 September 2023

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	BCG-unresponsive Patients
	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)
	NMIBC with Cis with or without resected papillary tumors who are ineligible for or
	have elected not to undergo cystectomy
	has had a hysterectomy or bilateral oophorectomy or
	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
	Performance Status: Eastern Cooperative Oncology Group (ECOG) 0, 1, and 2
	resection of bladder tumor (TURBT)
	Hematologic inclusion within 2 weeks of start of treatment
	All Patients
	Absolute neutrophil count >1,500/mm3
	Hemoglobin >9.0 g/dl
	Platelet count >100,000/mm3
	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
	In Phase 2, for patients with T1 lesions, Screening biopsy must be considered adequate
	double-barrier contraception, i.e., intrauterine device, birth control pills
	(contain the muscularis layer)
	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
	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
	Evidence of metastatic disease
	History of interstitial cystitis
	Known human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection
	History of partial cystectomy
	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 last therapeutic agent (including intravesical chemotherapy post-TURBT)
	Treatment with pembrolizumab within 30 days (Phase 1) or 3 months (Phase 2) prior to
	within 30 days of Screening (Phase 1 and Phase 2) or treatment with an investigational
	Screening
	checkpoint inhibitor within 3 months of Screening (Phase 2 only)
	Evidence of persistent or ongoing renal failure
	History of unresolved vesicoureteral reflux or an indwelling urinary stent
	History of unresolved hydronephrosis due to ureteral obstruction
	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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Study Definition

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LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve