The goal of this clinical trial is to learn the safety, tolerability, pharmacokinetic characteristics and efficacy of FC084CSA in combination with Tislelizumab in patients with advanced malignant solid tumors.
The study includes two phases. Phase Ib adopts a "3+3" dose escalation design to assess safety and tolerability of increasing dose levels of FC084CSA in combination of fixed dose of Tislelizumab. Phase IIa is the dose expansion phase to further observe the preliminary effectiveness of the recommended Phase 2 Dose of FC084CSA in combination of Tislelizumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Increasing dose levels of FC084CSA+fixed dose Tislelizumab combination therapy
RP2D of FC084CSA+fixed dose Tislelizumab combination therapy
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGDetermine the Maximum Tolerated Dose (MTD)
The highest dose is defined at which no more than 1 of 3 evaluable participants has had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria and determination by Investigator and Data and Safety Monitoring Committee.
Time frame: Approximately 8 months
Determine the Recommended Phase 2 Dose (RP2D)
The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.
Time frame: Approximately 8 months
Determine dose-limiting toxicity (DLT)
Determine the DLT of FC084CSA
Time frame: 21 days after first dose
Objective response rate (ORR)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1
Time frame: Approximately 12 months
Disease control rate (DCR)
DCR as assessed using RECIST 1.1
Time frame: Approximately 12 months
Progression free survival (PFS)
PFS as assessed using RECIST 1.1
Time frame: Approximately 12 months
Overal suvival (OS)
It is defined as the time from date of first dose to the date of death (due to any cause). Subjects who are alive will be censored at the last known alive dates.
Time frame: Approximately 18 months
Pharmacokinetic (PK) Cmax
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To investigate the pharmacokinetic (PK) profile of FC084CSA
Time frame: Approximately 12 months
Pharmacokinetic (PK) Tmax
To investigate the pharmacokinetic (PK) profile of FC084CSA
Time frame: Approximately 12 months
Pharmacokinetic (PK) AUC 0-t
To investigate the pharmacokinetic (PK) profile of FC084CSA
Time frame: Approximately 12 months
Pharmacokinetic (PK) AUC 0-∞
To investigate the pharmacokinetic (PK) profile of FC084CSA
Time frame: Approximately 12 months