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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
170
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.
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence of dose limiting toxicities (DLTs)
Time frame: From Day 1 to Day 21
Maximum tolerated dose (MTD)
Time frame: From Day 1 to Day 21
Incidence and severity of adverse events (AEs) ([CTCAE] v5.0)
Time frame: From Day 1 to 90 days after last dose
RP2D(Recommended Phase 2 dose)
Time frame: From Day 1 to 90 days after last dose
PK parameter: Tmax of SHR-2005
Time to maximum concentration of SHR-2005
Time frame: approximately 24 months
PK parameter: Cmax of SHR-2005
Maximum concentration of SHR-2005
Time frame: approximately 24 months
PK parameter: AUC0-∞ of SHR-2005
area under the concentration-time curve from time 0 to infinity of SHR-2005
Time frame: approximately 24 months
Immunogenicity of SHR-2005
Anti- SHR-2005 antibody (ADA)
Time frame: approximately 24 months
Duration of response (DoR)
Evaluated using RECIST 1.1
Time frame: approximately within 36 months
Disease control rate (DCR)
Evaluated using RECIST 1.1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: approximately within 36 months
Progression-free survival (PFS)
Evaluated using RECIST 1.1
Time frame: approximately within 36 months
Amount_recovered and Percent_recovered
The Amount \_ recovered and Percent \_ recovered of SHR-2005 in urine after intravesical instillation.
Time frame: approximately 24 months