A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors
- Conditions
- Advanced Malignant Solid Tumors
- Interventions
- Drug: FC084CSA+Tislelizumab combination (dose escalation)Drug: RP2D of FC084CSA+Tislelizumab combination (dose expansion)
- Registration Number
- NCT06499350
- Lead Sponsor
- FindCure Biosciences (ZhongShan) Co., Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 33
- 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;
- According to RECIST 1.1, there is at least one measurable lesion.
- ECOG performance status 0-1.
- Major organs are functioning well.
- 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.
- Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods.
- Central nervous system metastases with clinical symptoms.
- With any situations that the researcher considers inappropriate to participate in this research.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FC084CSA+Tislelizumab FC084CSA+Tislelizumab combination (dose escalation) This is a single arm phase I trial in a 3 + 3 dose escalation and cohort expansion design evaluating the safety and tolerability of FC084CSA in combination with Tislelizumab. Increasing dose levels of FC084CSA with fixed dose of Tislelizumab. Dose escalation continues until dose-limiting toxicities (DLT) are observed in one-third of participants. If no DLT occurs, the next cohort will be enrolled at the next planned dose level. If 1 DLT occurs in a cohort, another 3 patients will be treated with the same dose level. Following the definition of the recommended Phase 2 Dose (RP2D) of FC084CSA in dose escalation phase, NSCLC dose expansion cohort is planned to perform a preliminary assessment of the anti-tumour efficacy and to further establish the safety profile of the RP2D of FC084CSA in combination with Tislelizumab. FC084CSA+Tislelizumab RP2D of FC084CSA+Tislelizumab combination (dose expansion) This is a single arm phase I trial in a 3 + 3 dose escalation and cohort expansion design evaluating the safety and tolerability of FC084CSA in combination with Tislelizumab. Increasing dose levels of FC084CSA with fixed dose of Tislelizumab. Dose escalation continues until dose-limiting toxicities (DLT) are observed in one-third of participants. If no DLT occurs, the next cohort will be enrolled at the next planned dose level. If 1 DLT occurs in a cohort, another 3 patients will be treated with the same dose level. Following the definition of the recommended Phase 2 Dose (RP2D) of FC084CSA in dose escalation phase, NSCLC dose expansion cohort is planned to perform a preliminary assessment of the anti-tumour efficacy and to further establish the safety profile of the RP2D of FC084CSA in combination with Tislelizumab.
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) Approximately 12 months To explore the clinical effectiveness. Tumor response based on RECIST 1.1
Determine the Maximum Tolerated Dose (MTD) Approximately 8 months 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 dose-limiting toxicity (DLT) 21 days after first dose Determine the DLT of FC084CSA
Determine the Recommended Phase 2 Dose (RP2D) Approximately 8 months The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.
- Secondary Outcome Measures
Name Time Method Overal suvival (OS) Approximately 18 months 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.
Disease control rate (DCR) Approximately 12 months DCR as assessed using RECIST 1.1
Progression free survival (PFS) Approximately 12 months PFS as assessed using RECIST 1.1
Pharmacokinetic (PK) AUC 0-t Approximately 12 months To investigate the pharmacokinetic (PK) profile of FC084CSA
Pharmacokinetic (PK) Tmax Approximately 12 months To investigate the pharmacokinetic (PK) profile of FC084CSA
Pharmacokinetic (PK) Cmax Approximately 12 months To investigate the pharmacokinetic (PK) profile of FC084CSA
Pharmacokinetic (PK) AUC 0-∞ Approximately 12 months To investigate the pharmacokinetic (PK) profile of FC084CSA
Trial Locations
- Locations (1)
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China