Clinical Trials List
Protocol NumberCG3002S (BOND-003)
Active
2021-01-04 - 2026-04-30
Phase III
Recruiting4
ICD-10C67.0
Malignant neoplasm of trigone of bladder
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9188.0
Malignant neoplasm of trigone of urinary bladder
A Phase 3 Study of CG0070 in Patients with Non-Muscular Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)
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Trial Applicant
-
Sponsor
Novotech
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Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Yi-Huei Chang Division of Urology
- Po-Fan Hsieh Division of Urology
- Chi-Ping Huang Division of Urology
- Po-Jen Hsiao Division of Urology
- 陳冠亨 Division of Urology
- Hsi-Chin Wu Division of Urology
- Chi-Rei Yang Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張悅詩 Division of Hematology & Oncology
- Pei-Hung Chang Division of Hematology & Oncology
- 吳俊德 Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- - - Division of Urology
- YI-KAI CHANG Division of Urology
- - - Division of Urology
- JIAN-HUA HONG Division of Urology
- YU-CHUAN LU Division of Urology
- Yeong-Shiau Pu Division of Urology
- PO-MING CHOW Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tzu-Ping Lin Division of Urology
- 陳威任 Division of Urology
- Yen-Hwa Chang Division of Urology
- Tzu-Hao Huang Division of Urology
- 沈書慧 Division of Radiology
- Yi-Hsiu Huang Division of Urology
- Chih-Chieh Lin Division of Urology
- William Huang Division of Urology
- Tzu-chun Wei Division of Urology
- 潘競成 Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
This is a Phase 3, open-label, trial designed to evaluate CG0070 in patients with high-grade CIS of the bladder unresponsive to Bacillus Calmette-Guerin (BCG).
Objectives
This Phase 3 study is designed to evaluate the activity of intravesical (IVE) CG0070 in patients
with tissue pathology-confirmed high-grade non-muscular invasive bladder cancer (NMIBC) who
have Bacillus Calmette-Guerin (BCG) unresponsive disease with carcinoma in situ (CIS) with or
without Ta/T1 disease. The primary end point is defined as the complete response rate at any time
with secondary endpoints to include safety, duration of response, progression free survival,
cystectomy free survival, and overall survival. Tissue and body fluids will be collected to assess
immune response to virus and tumor as well as environmental shedding.
Test Drug
CG0070
DDM
DDM
Active Ingredient
CG0070
DDM
DDM
Dosage Form
Vial
Vial
Vial
Dosage
1.3 x 1012 vp/mL
50mg/mL
50mg/mL
Endpoints
To determine the complete response rate at any time in patients with carcinoma in situ
(CIS) (with or without concomitant high-grade Ta or T1 papillary disease)
(CIS) (with or without concomitant high-grade Ta or T1 papillary disease)
Inclution Criteria
Inclusion Criteria:
In order to be eligible for participation in this trial, patients must meet all of the following entry
criteria:
1. Be ≥18 years of age (or legal age of majority in the jurisdiction) on day of signing informed
consent
2. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
3. Have pathologically confirmed (World Health Organization [WHO] grading system
employed for tumor grading) (Compérat 2018) CIS unresponsive to prior BCG therapy.
Patients with CIS unresponsive to BCG are those unlikely to benefit from and who will not
be receiving further IVE BCG. There is no maximum limit to the amount of prior BCG past
treatment but maintenance BCG should be administered on a schedule consistent with
standard induction-maintenance protocols (e.g., BCG weekly x 6 then weekly x 3 weeks
administered at Months 3, 6, 12, 18, 24, and 36). The definition of BCG unresponsive CIS
will also require the following:
• Relapsed or persistent CIS within 12 months of the last dose of BCG treatment.
• Pathological confirmation of BCG unresponsive CIS within 10 weeks of study
enrollment.
• CIS specimen must be predominantly urothelial (transitional cell) and have less than
50% variant (e.g., sarcomatoid, squamous etc. component) histology.
• No maximum limit to the amount of BCG administered but maintenance BCG should
be administered on a schedule consistent with the SWOG 8507 regimen (Lamm 2000).
4. Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior
to study treatment (e.g., prior to Day 1 treatment). NOTE: T1 disease resection site must
have biopsy evaluation of the prior resection site 2–8 weeks prior to initial study treatment.
5. Received prior adequate BCG therapy defined as at least one of the following:
• At least 5 of 6 doses of an initial induction course (adequate induction) plus at least 2 of
3 doses of maintenance therapy, OR
• At least 5 of 6 doses of an initial induction course (adequate induction) plus at least 2 of
6 doses of a second induction course
6. Ineligible to receive radical cystectomy or refusal of radical cystectomy based on investigator
assessment
In order to be eligible for participation in this trial, patients must meet all of the following entry
criteria:
1. Be ≥18 years of age (or legal age of majority in the jurisdiction) on day of signing informed
consent
2. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
3. Have pathologically confirmed (World Health Organization [WHO] grading system
employed for tumor grading) (Compérat 2018) CIS unresponsive to prior BCG therapy.
Patients with CIS unresponsive to BCG are those unlikely to benefit from and who will not
be receiving further IVE BCG. There is no maximum limit to the amount of prior BCG past
treatment but maintenance BCG should be administered on a schedule consistent with
standard induction-maintenance protocols (e.g., BCG weekly x 6 then weekly x 3 weeks
administered at Months 3, 6, 12, 18, 24, and 36). The definition of BCG unresponsive CIS
will also require the following:
• Relapsed or persistent CIS within 12 months of the last dose of BCG treatment.
• Pathological confirmation of BCG unresponsive CIS within 10 weeks of study
enrollment.
• CIS specimen must be predominantly urothelial (transitional cell) and have less than
50% variant (e.g., sarcomatoid, squamous etc. component) histology.
• No maximum limit to the amount of BCG administered but maintenance BCG should
be administered on a schedule consistent with the SWOG 8507 regimen (Lamm 2000).
4. Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior
to study treatment (e.g., prior to Day 1 treatment). NOTE: T1 disease resection site must
have biopsy evaluation of the prior resection site 2–8 weeks prior to initial study treatment.
5. Received prior adequate BCG therapy defined as at least one of the following:
• At least 5 of 6 doses of an initial induction course (adequate induction) plus at least 2 of
3 doses of maintenance therapy, OR
• At least 5 of 6 doses of an initial induction course (adequate induction) plus at least 2 of
6 doses of a second induction course
6. Ineligible to receive radical cystectomy or refusal of radical cystectomy based on investigator
assessment
Exclusion Criteria
Exclusion Criteria:
The patient must be excluded from participating in the trial if the patient:
1. Has current or past history of muscle invasive (T2 or higher stage) or locally advanced
(T3/T4, any N) or metastatic bladder cancer
2. Has urothelial carcinoma in the upper genitourinary tract (kidneys, renal collecting systems,
ureters) or prostatic urethra (including CIS of the urethra) within 24 months of enrollment
3. Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks
of Day 1.
4. Has prior systemic treatment, radiation therapy, or surgery for bladder cancer other than
TURBT or bladder biopsies
5. Has any of the following within the 6 months prior to starting study treatment: myocardial
infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular
accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart
failure.
6. Has used excluded anti-viral medication (e.g., interferon/peg-interferon, ribavirin, etc.) within
14 days of Day 1 and that cannot be suspended throughout for at least 14 days prior to and
after each treatment with CG0070.
7. Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per
protocol biopsies and other procedures as per standard of care
8. Has significant immunodeficiency due to underlying illness (e.g., known HIV/AIDS)
9. Has received systemic immunosuppressive medication including high-dose corticosteroids
(e.g., systemic corticosteroids >10 mg prednisone or equivalent), within 4 weeks prior to
Day 1.
The patient must be excluded from participating in the trial if the patient:
1. Has current or past history of muscle invasive (T2 or higher stage) or locally advanced
(T3/T4, any N) or metastatic bladder cancer
2. Has urothelial carcinoma in the upper genitourinary tract (kidneys, renal collecting systems,
ureters) or prostatic urethra (including CIS of the urethra) within 24 months of enrollment
3. Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks
of Day 1.
4. Has prior systemic treatment, radiation therapy, or surgery for bladder cancer other than
TURBT or bladder biopsies
5. Has any of the following within the 6 months prior to starting study treatment: myocardial
infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular
accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart
failure.
6. Has used excluded anti-viral medication (e.g., interferon/peg-interferon, ribavirin, etc.) within
14 days of Day 1 and that cannot be suspended throughout for at least 14 days prior to and
after each treatment with CG0070.
7. Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per
protocol biopsies and other procedures as per standard of care
8. Has significant immunodeficiency due to underlying illness (e.g., known HIV/AIDS)
9. Has received systemic immunosuppressive medication including high-dose corticosteroids
(e.g., systemic corticosteroids >10 mg prednisone or equivalent), within 4 weeks prior to
Day 1.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
115 participants
