A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат FC084CSA+Tislelizumab combination (dose escalation)
  Increasing dose levels of FC084CSA+fixed dose Tislelizumab combination therapy
• Препарат RP2D of FC084CSA+Tislelizumab combination (dose expansion)
  RP2D of FC084CSA+fixed dose Tislelizumab combination therapy

Первичные конечные точки

• Determine the Maximum Tolerated Dose (MTD) [Срок оценки: Approximately 8 months]
• Determine the Recommended Phase 2 Dose (RP2D) [Срок оценки: Approximately 8 months]
• Determine dose-limiting toxicity (DLT) [Срок оценки: 21 days after first dose]
• Objective response rate (ORR) [Срок оценки: Approximately 12 months]

Вторичные конечные точки (7)

• Disease control rate (DCR) [Срок оценки: Approximately 12 months]
• Progression free survival (PFS) [Срок оценки: Approximately 12 months]
• Overal suvival (OS) [Срок оценки: Approximately 18 months]
• Pharmacokinetic (PK) Cmax [Срок оценки: Approximately 12 months]
• Pharmacokinetic (PK) Tmax [Срок оценки: Approximately 12 months]
• Pharmacokinetic (PK) AUC 0-t [Срок оценки: Approximately 12 months]
• Pharmacokinetic (PK) AUC 0-∞ [Срок оценки: Approximately 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai East Hospital — Шанхай

Идентификаторы

NCT: NCT06499350 · FC084-CA-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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