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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FC084CSA+Tislelizumab | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FC084CSA+Tislelizumab combination (dose escalation) | Drug | Increasing dose levels of FC084CSA+fixed dose Tislelizumab combination therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Approximately 8 months |
| Determine dose-limiting toxicity (DLT) | Determine the DLT of FC084CSA | 21 days after first dose |
| Objective response rate (ORR) | To explore the clinical effectiveness. Tumor response based on RECIST 1.1 | Approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | DCR as assessed using RECIST 1.1 | Approximately 12 months |
| Progression free survival (PFS) | PFS as assessed using RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingjin Wang | Contact | 18664044814 | wangtingjin@find-cure.com |
| Name | Affiliation | Role |
|---|---|---|
| Caicun Zhou | Shanghai East Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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FC084CSA in combination with Tislelizumab
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| RP2D of FC084CSA+Tislelizumab combination (dose expansion) | Drug | RP2D of FC084CSA+fixed dose Tislelizumab combination therapy |
|
|
| 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. | Approximately 18 months |
| Pharmacokinetic (PK) Cmax | To investigate the pharmacokinetic (PK) profile of FC084CSA | Approximately 12 months |
| Pharmacokinetic (PK) Tmax | To investigate the pharmacokinetic (PK) profile of FC084CSA | Approximately 12 months |
| Pharmacokinetic (PK) AUC 0-t | To investigate the pharmacokinetic (PK) profile of FC084CSA | Approximately 12 months |
| Pharmacokinetic (PK) AUC 0-∞ | To investigate the pharmacokinetic (PK) profile of FC084CSA | Approximately 12 months |