This trial is designed to evaluate the safety and efficacy of anti-IGF-1R mAb in combination with anti-PD-1 mAb in patients with mCRPC.
This trial is designed to primarily confirm the safety and tolerability of anti-IGF-1R mAb (Teprotumumab/IBI311) in combination with anti-PD-1 mAb (Tislelizumab) using the recommended dose level for patients with mCRPC patients. Additionally,this trial is aimed to evaluate the clinical efficacy of anti-IGF-1R mAb combined with anti-PD-1 mAb in the treatment of mCRPC patients and to investigate whether the combined treatment can enhance endocrine therapy sensitivity in mCRPC patients. As for exploratory objectives,the trial is designed to identify and validate predictive biomarkers associated with therapeutic efficacy and safety profiles of the combination regimen in mCRPC patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Drug: Teprotumumab/IBI311 Given by IV infusion Initiate dosing with 10 mg/kg for first infusion, followed by 20 mg/kg every 3 weeks. Drug: Tislelizumab Given by IV infusion 200 mg every 3 weeks
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Safety and adverse event incidence rate
Incidence rate of adverse events graded according to the National Cancer Institute Common Criteria for Adverse Events (NCI CTCAE) version 5.0.
Time frame: Through primary completion of study which may take up to 6 months.
3-month PSA progression-free survival (PSA-PFS)
Time from enrollment to PSA progression as defined by PCWG3 or patient death.
Time frame: 3 months after first infusion
6-month imaging progression-free survival (rPFS):
Time from enrollment to imaging progression or death from any cause, to be evaluated in conjunction with the RECIST 1.1 criteria and the PCWG3 criteria.
Time frame: 6 months after first infusion
6-month PSA progression-free survival (PSA-PFS)
Time from enrollment to PSA progression as defined by PCWG3 or patient death.
Time frame: 6 months after first infusion
PSA Response Rate
Percentage of PSA decline from baseline according to PCWG3 criteria
Time frame: Through primary completion of study which may take up to 6 months.
Disease Control Rate
Defined as the proportion of patients whose tumors shrunk or remained stable for a certain period of time after treatment, judged according to RECIST 1.1 and PCWG3 to include the proportion of patients with complete remission (CR), partial remission (PR), and stable disease (SD).
Time frame: Through primary completion of study which may take up to 6 months.
Objective Response Rate
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Define the proportion of patients with disease CR or PR as determined by RECIST 1.1 and PCWG3 , after treatment;
Time frame: Through primary completion of study which may take up to 6 months.
Overall Survival
Defined as the time from randomization grouping to the last available assessment or death;
Time frame: Through primary completion of study which may take up to 6 months.
Incidence of bone metastasis-related events (SREs)
Incidence of bone radiotherapy (including radioisotopes), pathologic fractures (excluding trauma), spinal cord compression, and bone surgery.
Time frame: Through primary completion of study which may take up to 6 months.
Quality of life (QoL)
QoL was monitored using the validated and self-rated EORTCQLQ-C30
Time frame: Through primary completion of study which may take up to 6 months.
Quality of life (QoL) FACT-P questionnaire
QoL was monitored using the validated and self-rated questionnaire
Time frame: Through primary completion of study which may take up to 6 months.
Time to pain progression
Time from the date of randomization to the date on which the pain severity score (using the BPI-SF) increased by 30% or more from baseline. Or the time from the date of randomization to the date of observation of a 2-point increase from baseline in the BPI-SF worst pain intensity (point 3 on the scale) on 2 consecutive assessments ≥4 weeks apart or initiation of chronic opioid use, whichever occurred first.
Time frame: Through primary completion of study which may take up to 6 months.