NCT04042116暂停1 期
LIO-1: A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With An Advanced, Metastatic Solid Tumor
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 227
- 试验地点
- 27
- 主要终点
- Best Overall Response Rate (Phase 2)
研究概览
简要总结
This is an open-label, Phase 1b/2 study to determine the recommended dose of lucitanib in combination with nivolumab in patients with an advanced solid tumor (Phase 1b); followed by evaluation of the safety and efficacy of lucitanib and nivolumab in patients with an advanced gynecological solid tumor (Phase 2) and evaluate the effects of dosing under fasting or fed state (Food Effect)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Adequate organ function
- •Life expectancy ≥ 3 months
- •Women of childbearing potential must have a negative serum pregnancy test
- •Advanced/metastatic solid tumor (Phase 1b)
- •Availability of tumor tissue at screening
- •ECOG performance status of 0 to 1
- •Measurable disease (RECIST v1.1) (Phase 2)
- •Advanced, recurrent, or metastatic gynecological solid tumor (Phase 2)
- •Willing and able to fast, and to eat a high-fat breakfast (Food Effect)
排除标准
- •Prior treatment with lucitanib
- •Active second malignancy
- •Active central nervous system brain metastases
- •Pre-existing duodenal stent or any gastrointestinal disorder
- •Known history of HIV or AIDs; positive result of hepatitis B or C viruses
- •Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis
- •Active, known or suspected autoimmune disease (eg, autoimmune hepatitis)
- •Condition requiring systemic treatment with corticosteroids or other immune suppressive medications
- •Unstable or uncontrolled hypertension (BP ≥ 140/90 mmHg)
- •Prior treatment with a VEGFR-tyrosine kinase inhibitor (Phase 2)
研究组 & 干预措施
Phase 1b: Dose Escalation
Experimental
- Up to 50 patients with advanced solid tumor
干预措施: Lucitanib (Drug)
Phase 1b: Dose Escalation
Experimental
- Up to 50 patients with advanced solid tumor
干预措施: Nivolumab (Drug)
Phase 1b: Food Effect Cohort
Experimental
- Approximately 16 evaluable patients with an advanced, metastatic solid tumor will be enrolled
干预措施: Lucitanib (Drug)
Phase 1b: Food Effect Cohort
Experimental
- Approximately 16 evaluable patients with an advanced, metastatic solid tumor will be enrolled
干预措施: Nivolumab (Drug)
Phase 2: Expansion Cohort - Endometrial Cancer
Experimental
- Recurrent endometrial carcinoma at least 1 prior platinum-based chemotherapy regimen
- Up to 10 patients who have progressed on treatment with 1 prior PD-(L)1 inhibitor administered as monotherapy will be allowed to enroll
干预措施: Lucitanib (Drug)
Phase 2: Expansion Cohort - Endometrial Cancer
Experimental
- Recurrent endometrial carcinoma at least 1 prior platinum-based chemotherapy regimen
- Up to 10 patients who have progressed on treatment with 1 prior PD-(L)1 inhibitor administered as monotherapy will be allowed to enroll
干预措施: Nivolumab (Drug)
Phase 2: Expansion Cohort - Ovarian Cancer
Experimental
- Recurrent high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, of any histology excluding clear cell carcinoma
- At least 2 prior chemotherapy regimens which at least 1 must have been platinum-doublet chemotherapy
- Up to 10 subjects with recurrent ovarian, fallopian tube, or primary peritoneal cancer, of any histology excluding clear cell carcinoma who have progressed within 6 months after completing first-line platinum-based chemotherapy will be allowed to enroll
干预措施: Lucitanib (Drug)
Phase 2: Expansion Cohort - Ovarian Cancer
Experimental
- Recurrent high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, of any histology excluding clear cell carcinoma
- At least 2 prior chemotherapy regimens which at least 1 must have been platinum-doublet chemotherapy
- Up to 10 subjects with recurrent ovarian, fallopian tube, or primary peritoneal cancer, of any histology excluding clear cell carcinoma who have progressed within 6 months after completing first-line platinum-based chemotherapy will be allowed to enroll
干预措施: Nivolumab (Drug)
Phase 2: Expansion Cohort - Clear Cell Cancer
Experimental
- Recurrent, metastatic clear cell carcinoma of ovarian, fallopian tube, primary peritoneal or endometrial origin
- At least 1 prior platinum- and taxane-based chemotherapy regimen
干预措施: Lucitanib (Drug)
Phase 2: Expansion Cohort - Clear Cell Cancer
Experimental
- Recurrent, metastatic clear cell carcinoma of ovarian, fallopian tube, primary peritoneal or endometrial origin
- At least 1 prior platinum- and taxane-based chemotherapy regimen
干预措施: Nivolumab (Drug)
Phase 2: Expansion Cohort - Cervical Cancer
Experimental
- Persistent or recurrent cervix cancer of squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma histology
- At least 1 prior regimen of platinum-based chemotherapy, with or without bevacizumab, for metastatic disease
干预措施: Lucitanib (Drug)
Phase 2: Expansion Cohort - Cervical Cancer
Experimental
- Persistent or recurrent cervix cancer of squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma histology
- At least 1 prior regimen of platinum-based chemotherapy, with or without bevacizumab, for metastatic disease
干预措施: Nivolumab (Drug)
结局指标
主要结局
Best Overall Response Rate (Phase 2)
时间窗: From first dose of study drug until disease progression (up to approximately 2 years)
Confirmed best overall response (PR or CR) based on investigator assessment of objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Determine the recommended Phase 2 dose of the combination of lucitanib and nivolumab (Phase 1b)
时间窗: First dose of study drug through at least 100 days after end of treatment (up to approximately 2 years)
Incidence of adverse events and clinical lab abnormalities defined as dose-limiting toxicities and maximum tolerated dose.
次要结局
- Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect, Phase 2](From Cycle 2 to Cycle 5 (each cycle is 28 days))
- The effect of food (fasted or fed) on the Lucitanib PK Profile [Food Effect Cohort](From first dose of study drug to Day -1)
- Further evaluation of preliminary efficacy of combination (Phase 2)(From first dose of study drug until at least 100 days after end of treatment (up to approximately 2 years))
- Lucitanib PK Profile at single dose [Food Effect Cohort](From first dose of study drug to Day -1)
- Acute and long-term safety and tolerability of the combination (Phase 2)(From first dose of study drug until disease progression (up to approximately 2 years))
- Lucitanib PK Profile at Steady State [Phase 1 dose escalation and Food Effect](From first dose of study drug to the end of Cycle 1 (each cycle is 28 days))
研究者
研究点 (27)
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