Clinical trial NCT06499350: A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Malignant Solid Tumors
Lead sponsor: FindCure Biosciences (ZhongShan) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-12
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: FC084CSA in combination with Tislelizumab
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 75 years old male and female.
2. 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.
3. No known sensitizing mutations or other actionable oncogenes with approved therapies if available.
4. Prior PD-1/PD-L1 inhibitor combined with platinum-containing therapy failed;
5. According to RECIST 1.1, there is at least one measurable lesion.
6. ECOG performance status 0-1.
7. Major organs are functioning well.

Exclusion Criteria:

1. Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).
2. Received anti-tumor therapy within 4 weeks before enrollment.
3. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
4. 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.
5. Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods.
6. Central nervous system metastases with clinical symptoms.
7. With any situations that the researcher considers inappropriate to participate in this research.

Primary outcomes:
measure: Determine the Maximum Tolerated Dose (MTD)
timeFrame: Approximately 8 months
measure: Determine the Recommended Phase 2 Dose (RP2D)
timeFrame: Approximately 8 months
measure: Determine dose-limiting toxicity (DLT)
timeFrame: 21 days after first dose
measure: Objective response rate (ORR)
timeFrame: Approximately 12 months
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: Approximately 12 months
measure: Progression free survival (PFS)
timeFrame: Approximately 12 months
measure: Overal suvival (OS)
timeFrame: Approximately 18 months
measure: Pharmacokinetic (PK) Cmax
timeFrame: Approximately 12 months
measure: Pharmacokinetic (PK) Tmax
timeFrame: Approximately 12 months
measure: Pharmacokinetic (PK) AUC 0-t
timeFrame: Approximately 12 months
measure: Pharmacokinetic (PK) AUC 0-∞
timeFrame: Approximately 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital
name: Caicun Zhou
role: PRINCIPAL_INVESTIGATOR
References: