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.
Aged 18 to 75 years old male and female.
Phase Ib: Patients with histologically or cytologically diagnosed solid tumors who have failed standard therapy; Phase IIa: Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV NSCLC which surgery or radiotherapy cannot be performed.
No known sensitizing mutations or other actionable oncogenes with approved therapies if available.
Prior PD-1/PD-L1 inhibitor combined with platinum-containing therapy failed;
Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).
Received anti-tumor therapy within 4 weeks before enrollment.
Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
Have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started.
Single group
FC084CSA+Tislelizumab combination (dose escalation)
DrugIncreasing dose levels of FC084CSA+fixed dose Tislelizumab combination therapy
RP2D of FC084CSA+Tislelizumab combination (dose expansion)
DrugRP2D of FC084CSA+fixed dose Tislelizumab combination therapy
Determine 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.
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.
Determine dose-limiting toxicity (DLT)
Determine the DLT of FC084CSA
Objective response rate (ORR)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1
Disease control rate (DCR)
DCR as assessed using RECIST 1.1
Progression free survival (PFS)
PFS as assessed using RECIST 1.1
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.
Pharmacokinetic (PK) Cmax
To investigate the pharmacokinetic (PK) profile of FC084CSA
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