Study of CG0070 After Transurethral Resection in Patients With IR NMIBC

NCT06253845 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: MCC-21690
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators will evaluate the safety of CG0070 for the treatment of patients with Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC).

Conditions

Non-muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Adverse events Grade 3 or higher will be graded according to the NC Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  Up to 2 years

Secondary Outcomes (5)

• Complete Response Rate (CR)

  12 weeks

• 12-month recurrence free survival rate (RFS)

  12 months

• 24-month recurrence free survival rate (RFS)

  24 months

• Progression free survival (PFS)

  Up to 24 months

• Cystectomy free survival (CFS)

  Up to 24 months

Study Arms (1)

CG0070

EXPERIMENTAL

CG0070 is a conditionally replicating oncolytic adenovirus (serotype 5) designed to preferentially replicate in and kill cancer cells.

Biological: CG0070

Interventions

CG0070 BIOLOGICAL

CG0070 will be administered at a dose of 1x10\^12 vp intravesically following a sequence of bladder washes with DDM and normal saline.

CG0070

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Have pathologically confirmed:
• Recurrent Low-grade Ta
• Solitary Low-Grade Ta \> 3cm
• Low-grade Ta multifocal
• High-grade Ta ≤ 3cm
• Have all visible disease except a single "marker lesion" of approximately 0.3 - 1 cm diameter removed at baseline prior to initial CG0070 treatment (photographic documentation of lesion location and size must be conducted). "Marker lesion" must be clearly identifiable and assessable in the judgment of the investigator. "Marker lesion" location and size must be documented by the investigator (e.g., via photography).
• Demonstrate adequate organ function, defined as:
• Aspartate transaminase (AST), alanine aminotransferase (ALT)
• ≤2.5 × upper limit of normal (ULN)
• Total serum bilirubin ≤1.5 × ULN (OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN)
• Absolute neutrophil count (ANC) ≥1,000 cells/mm3
• Hemoglobin ≥8 g/dL or ≥4.96 mmol/L
• Platelet count ≥100,000 platelets/mm3
• Serum creatinine ≤1.5 × ULN or creatinine clearance ≥30 mL/min for patient with creatinine levels \>1.5 institutional ULN according to Cockcroft-Gault formula

You may not qualify if:

• Current or prior evidence of high-risk NMIBC defined as:
• HG T1
• Any recurrent HG (G3) Ta
• HG Ta \> 3 cm (or multifocal)
• Any CIS
• Any BCG exposure in HG patient
• Any variant histology
• Any LVI
• Any HG prostatic urethral involvement
• Disease that is unable to be completely resected
• Lack of marker lesion
• Low-risk NMIBC defined as:
• Low grade solitary Ta less than or equal to 3cm
• Papillary urothelial neoplasm of low malignant potential
• Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Roger Li, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)