The study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG or SHR-1316 in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG or SHR-1316. To evaluate the preliminary efficacy of SHR-1501 alone or in combination with BCG or SHR-1316 in the treatment of NMIBC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
SHR-1501 single agent dose escalation, and in combination of BCG or SHR-1316.
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGDose-limiting toxicity
Time frame: 21 Days
Maximum tolerated dose
Time frame: Approximately 2years
Recommended Phase 2 dose (RP2D)
Time frame: Approximately 2 years.
CR Rate (cohort 2)
Time frame: Approximately 4 years.
12-month DFS Rate (cohort 1、3、4)
Time frame: Approximately 4 years
Treatment-Related Adverse Events as assessed by CTCAE v5.0
Time frame: Approximately 4 years.
Duration of CR (DoR)
Time frame: Approximately 4 years.
CR rate at 6 months and 18 months
Time frame: Approximately 4 years.
DFS
Time frame: Approximately 4 years.
Time to cystectomy,
Time frame: Approximately 4 years.
Radical cystectomy rate;
Time frame: Approximately 4 years.
The amount of drug recovered in perfusate and urine after SHR-1501 perfusion
Time frame: Approximately 5 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Maximum concentration (Cmax) of SHR-1501
Time frame: Approximately 2 years, if applicable
Time to maximum concentration (Tmax) of SHR-1501
Time frame: Approximately 2 years,if applicable
Areas under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of SHR-1501
Time frame: Approximately 2 years,if applicable
Areas under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of SHR-1501
Time frame: Approximately 2 years,if applicable
Half-life (t1/2) of SHR-1501
Time frame: Approximately 2 years, if applicable
Apparent clearance (CL/F) of SHR-1501
Time frame: Approximately 2 years, if applicable
Apparent volume of distribution (V/F) of SHR-1501
Time frame: Approximately 2 years, if applicable
Concentration of SHR-1501 in Urine
Time frame: Approximately 2 years, if applicable
Anti-drug antibody of SHR-1501
Time frame: Approximately 2 years
Neutralizing antibody of SHR-1501
Time frame: Approximately 2 years