StudyFinder
A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients with BCG-Unresponsive NMIBC
Status: Recruiting
This study will evaluate the safety and tolerability of EG 70, a gene therapy, which is given inside the bladder. This study will measure its effectiveness on eliminating bladder tumors in participants with NMIBC who have failed or did not receive adequate Bacillus Calmette- Guérin (BCG) therapy. The study drug will be given into the lining of the bladder. This may cause an immune response inside the bladder and kill the cancer cells.
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• BCG-unresponsive NMIBC with carcinoma in situ (CIS
• ineligible for or have elected not to undergo cystectomy
• women of childbearing potential must be willing to use highly effective birth control methods; Males are required to use a condom for the duration of the study treatment through 3 months post-dose
• at least walking and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:
• other active cancer that required treatment in the past two years
• history of partial cystectomy
• history of severe asthma or other respiratory diseases
• human immunodeficiency virus, Hepatitis B, or Hepatitis C infection
• see link to clinicaltrials.gov for complete exclusion criteria
Interventions:
Drug: EG-70 (phase 1), Drug: EG-70 (phase 2)
Conditions:
Cancer
Keywords:
Bladder Cancer With Carcinoma in Situ, CIS, Clinics and Surgery Center (CSC), NMIBC
Study Contact: Merry Cunningham - mcunning@umn.edu
Principal Investigator: Joseph Zabell
Phase: PHASE1
IRB Number: SITE00001148
See this study on ClinicalTrials.gov