Superficial Bladder Cancer study: EG-70
Official title LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
ClinicalTrials.gov ID: NCT04752722
What this study is testing
What is EG-70?
an investigational bladder‑instilled gene therapy being studied for superficial bladder cancer (non‑muscle‑invasive bladder cancer). is designed to deliver a gene to the bladder lining to trigger a local immune response against tumor cells.
Also referred to as detalimogene.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if EG‑70 is safe and how well it works in treating non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) that is BCG‑unresponsive or high‑risk.
- Who it's for
- It is looking for adults with NMIBC and CIS who have not responded to BCG or who are at high risk for cancer recurrence.
- What's involved
- Participants will receive EG‑70 directly into the bladder. In Phase 1, doses will be increased to find the safest amount. In Phase 2, the chosen dose will be tested for effectiveness. Some patients may also get a special bladder rinse before the treatment.
- Time commitment
- The study lasts about 12 months, with several clinic visits for treatment, monitoring, and safety checks.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients who have previously been treated with a checkpoint inhibitor and failed treatment are eligible for inclusion 30 days post-treatment (Phase...
- Male or non-pregnant, non-lactating female, 18 years or older.
- Women of childbearing potential must have a negative pregnancy test at Screening.
- Female patients of childbearing potential must be willing to consent to using highly effective birth control methods
- In Phase 2, for patients with T1 lesions may be eligible after repeat TURBT if pathology shows non-invasive (Ta or less) or no disease.
You likely can't join if
- Active malignancies (i.e., progressing or requiring treatment change in the last 24 months). Exceptions allowed under Sponsor review.
- Concurrent treatment with any chemotherapeutic agent.
- History of partial cystectomy.
- Treatment with last therapeutic agent (including intravesical chemotherapy post-TURBT) within 30 days of Screening (prior to the screening biopsy).
- Patients who have received systemic immunosuppressive medication including high-dose corticosteroids.
- History of severe asthma or other respiratory diseases.
See the full eligibility criteria
- Patients who have previously been treated with a checkpoint inhibitor 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.
- Female patients of childbearing potential must be willing to consent to using highly effective birth control methods
- In Phase 2, for patients with T1 lesions may be eligible after repeat TURBT if pathology shows non-invasive (Ta or less) or no disease.
- Performance Status: Eastern Cooperative Oncology Group 0, 1, and 2.
- Hematologic inclusion: a. Absolute neutrophil count \>1,500/mm3. b. Hemoglobin \>9.0 g/dL. c. Platelet count \>100,000/mm3.
- Hepatic inclusion: a. Total bilirubin must be ≤1.5 x the upper limit of normal (ULN). b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤2.5 x ULN.
- Adequate renal function with creatinine clearance \>30 mL/min
- Prothrombin time and partial thromboplastin time ≤1.25 x ULN or within the therapeutic range if on anticoagulation therapy.
- Must have satisfactory bladder function with ability to retain study drug for 60 minutes.
- Active malignancies (i.e., progressing or requiring treatment change in the last 24 months). Exceptions allowed under Sponsor review.
- Concurrent treatment with any chemotherapeutic agent.
- History of partial cystectomy.
- Treatment with last therapeutic agent (including intravesical chemotherapy post-TURBT) within 30 days of Screening (prior to the screening biopsy).
- Patients who have received systemic immunosuppressive medication including high-dose corticosteroids.
- History of severe asthma or other respiratory diseases.
- 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 30 Days prior to screening or any prior treatment of NMIBC with any investigational gene or immunotherapy agent.
- History of external beam radiation to the pelvis 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.
- Evidence of metastatic disease.
- History of difficult catheterization that in the opinion of the Investigator will prevent administration of EG-70.
- Active interstitial cystitis on cystoscopy or biopsy.
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Known human immunodeficiency virus, Hepatitis B, or Hepatitis C infection.
- Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial infarction within 6 months).
- Hypersensitivity to any of the excipients of the study drug. Exclusionary for Bladder Rinse cohorts: known allergy to polidocanol
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Little Rock, Arkansas, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Lakewood, Colorado, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Greenwood, Indiana, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Hanover, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
+ 63 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Little Rock, Arkansas, United States; Irvine, California, United States; La Jolla, California, United States; Los Angeles, California, United States and 77 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.