Intermediate and High-risk Non-muscle Invasive Bladder Cancer
Conditions
Brief summary
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.
Interventions
DRUGSHR-2005
In dose Escalation: Four dose levels are preset. The administration cycle included 6 times of induction perfusion period and 15 times of maintenance perfusion period. In indication Expansion: Indications will be selected to evaluate preliminary efficacy.
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form; 2. ≥18 years of age, either sex; 3. Previous pathological biopsy was diagnosed as intermediate or high-risk NMIBC ; 4. ECOG performance status of 0-1; 5. Life expectancy ≥ 2 years; 6. Adequate bone marrow and organ function.
Exclusion criteria
1. Received TURBT or other surgical treatment or radiotherapy for bladder lesions within 2 weeks before the first administration; 2. Patients who were receiving treatment in other clinical trials or less than 4 weeks from the end of the first administration in this study; 3. History of serious cardiovascular and cerebrovascular diseases; 4. Severe infection within 2 weeks prior to the first dose; 5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0; 6. Oversize surgery or severe trauma within 4 weeks before the first use of research drugs; 7. Previously received any TNFR agonist antibody therapy, such as OX40, CD137, CD27, CD357 antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs) ([CTCAE] v5.0) | From Day 1 to 90 days after last dose |
| RP2D（Recommended Phase 2 dose） | From Day 1 to 90 days after last dose |
| Incidence of dose limiting toxicities (DLTs) | From Day 1 to Day 21 |
| Maximum tolerated dose (MTD) | From Day 1 to Day 21 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DoR) | approximately within 36 months | Evaluated using RECIST 1.1 |
| Disease control rate (DCR) | approximately within 36 months | Evaluated using RECIST 1.1 |
| PK parameter: Tmax of SHR-2005 | approximately 24 months | Time to maximum concentration of SHR-2005 |
| Amount_recovered and Percent_recovered | approximately 24 months | The Amount \_ recovered and Percent \_ recovered of SHR-2005 in urine after intravesical instillation. |
| Progression-free survival (PFS) | approximately within 36 months | Evaluated using RECIST 1.1 |
| PK parameter: Cmax of SHR-2005 | approximately 24 months | Maximum concentration of SHR-2005 |
| PK parameter: AUC0-∞ of SHR-2005 | approximately 24 months | area under the concentration-time curve from time 0 to infinity of SHR-2005 |
| Immunogenicity of SHR-2005 | approximately 24 months | Anti- SHR-2005 antibody (ADA) |
Countries
China
Contacts
Primary ContactShouwei Zhao
Outcome results
None listed