Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-center, single-arm, phase Ib/II study, aimed at assessing the safety and efficacy of SHR-1501 in combination with SHR-2005 as treatment for patients with high-risk non-muscle invasive bladder cancer (HR NMIBC) which is not completely resectable by transurethral resection of bladder tumor (TURBt).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm:SHR-1501+SHR-2005 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1501+SHR-2005 | Drug | SHR-1501, instillationï¼›SHR-2005, instillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I : Incidence of dose limiting toxicities (DLTs) | From Day 1 to Day 21 | |
| Phase I : RP2D(Recommended Phase 2 dose) | From Day 1 to 90 days after last dose | |
| Phase I : Incidence and severity of adverse events (AEs) | From Day 1 to 90 days after last dose | |
| Phase II : CR rate at 3 months | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I : CR rate at 3 months | From Day 1 to 90 days after last dose | |
| Phase II : Incidence and severity of adverse events (AEs) | Approximately 2 years | |
| Phase Ib/II: PR rate at 3 months |
Not provided
Inclusion Criteria:
Age ≥18 years old, both genders
Previous pathological biopsy was diagnosed as high-risk NMIBC
Tumors cannot be completely resected by TURBT(at least 2 senior urologists assessed that the lesion area is too extensive to be completely resected)
Ineligible or unwilling to undergo radical cystectomy
TURBT was performed within 6 weeks
Agreed to provide cystoscopic biopsy specimens for review
ECOG performance status of 0-2
Life expectancy ≥ 2 years
Adequate organ function:
Female or male subjects of childbearing age who have not undergo surgical sterilization shall agree to use contraceptive measures (such as intrauterine device and contraceptive pill) during the study treatment period and within 3 months after the end of the study treatment period, and both female subjects and female partners of male subjects should use highly effective contraceptive methods; the Female subjects of childbearing age who have not undergone surgical sterilization must have a negative serum HCG test result within 7 days prior to the first administration and must be non-lactating.
Volunteered to join the study, signed the informed consent, and had good compliance with follow-up
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dingwei Ye, MD | Contact | 86-21-64175590 | dwyeli@163.com | |
| Xiaolin Lu, MD | Contact | 86-21-64175590 |
| Name | Affiliation | Role |
|---|---|---|
| Dingwei Ye, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Approximately 2 years |
| Phase Ib/II: CR rate at 6 months and 12months | Approximately 2 years |
| Phase Ib/II: Duration of CR (DoR) | Approximately 2 years |
| Phase Ib/II: Cystectomy-Free Survival (CFS) | Approximately 2 years |
| D001749 |
| Urinary Bladder Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |