A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) and High-Risk NMIBC Patients who are BCG Naïve or Received Incomplete BCG Treatment

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512900-20-00

Acronym

EG-70-101

Enrollment

Registered

2024-12-23

Start date

2025-01-30

Completion date

Unknown

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-muscle invasive bladder cancer (NMIBC)

Brief summary

Percentage of patients with cystoscopic CR at 48 weeks, based on cystoscopic exam, urine cytology, and biopsies with central laboratory confirmation of pathology., Nature, incidence, relatedness, and severity of treatment-emergent AEs (as assessed by CTCAE v5.0).

Detailed description

1. Progression-free survival, 2. Recurrence-free survival among responders., 3. CR rate at 12, 24, 36, and 96 weeks, as well as CR rate by 24 and 48 weeks, and overall treatment CR including Maintenance Period., 4. Duration of response, 5. Cystectomy-free survival., 6. CR rate at week 48 as assessed by the Investigator, 7. Health-related quality of life (EORTC Quality of Life Questionnaire Core 30 [QLQ-C30] and NMIBC-24), Other endpoints: Anti-drug antibodies, EG-70 plasmid DNA in urine and blood, levels of IL-12 gene expression and RIG-I activators and/or biomarkers in specimens

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of patients with cystoscopic CR at 48 weeks, based on cystoscopic exam, urine cytology, and biopsies with central laboratory confirmation of pathology., Nature, incidence, relatedness, and severity of treatment-emergent AEs (as assessed by CTCAE v5.0).	—

Secondary

Measure	Time frame
1. Progression-free survival, 2. Recurrence-free survival among responders., 3. CR rate at 12, 24, 36, and 96 weeks, as well as CR rate by 24 and 48 weeks, and overall treatment CR including Maintenance Period., 4. Duration of response, 5. Cystectomy-free survival., 6. CR rate at week 48 as assessed by the Investigator, 7. Health-related quality of life (EORTC Quality of Life Questionnaire Core 30 [QLQ-C30] and NMIBC-24), Other endpoints: Anti-drug antibodies, EG-70 plasmid DNA in urine and blood, levels of IL-12 gene expression and RIG-I activators and/or biomarkers in specimens	—

Measure

Time frame

—

Countries

France, Germany, Italy, Spain

Outcome results