A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FC084CSA+Tislelizumab combination (dose escalation), RP2D of FC084CSA+Tislelizumab combination (dose expansion).
- Who it may be relevant to
- Registry conditions: Advanced Malignant Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of AXL Inhibitor FC084CSA Tablets in Combination With Tislelizumab in the Treatment of Advanced Malignant Solid Tumors
Overview
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.
Interventions
- Drug FC084CSA+Tislelizumab combination (dose escalation)
Increasing dose levels of FC084CSA+fixed dose Tislelizumab combination therapy - Drug RP2D of FC084CSA+Tislelizumab combination (dose expansion)
RP2D of FC084CSA+fixed dose Tislelizumab combination therapy
Primary outcome measures
- Determine the Maximum Tolerated Dose (MTD) [Time frame: Approximately 8 months]
- Determine the Recommended Phase 2 Dose (RP2D) [Time frame: Approximately 8 months]
- Determine dose-limiting toxicity (DLT) [Time frame: 21 days after first dose]
- Objective response rate (ORR) [Time frame: Approximately 12 months]
Secondary outcome measures (7)
- Disease control rate (DCR) [Time frame: Approximately 12 months]
- Progression free survival (PFS) [Time frame: Approximately 12 months]
- Overal suvival (OS) [Time frame: Approximately 18 months]
- Pharmacokinetic (PK) Cmax [Time frame: Approximately 12 months]
- Pharmacokinetic (PK) Tmax [Time frame: Approximately 12 months]
- Pharmacokinetic (PK) AUC 0-t [Time frame: Approximately 12 months]
- Pharmacokinetic (PK) AUC 0-∞ [Time frame: Approximately 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai East Hospital — Shanghai
Identifiers
NCT: NCT06499350 · FC084-CA-102