NCT04725994进行中（未招募）1 期
An Open-Label, International, Multicenter, Phase 1b/2a Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX (Capecitabine and Oxaliplatin) or Irinotecan in Patients With Advanced Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 87
- 试验地点
- 23
- 主要终点
- Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
研究概览
简要总结
This is an open-label, Phase 1b/2a study to evaluate the safety and tolerability of IDX-1197 and determine the MTD and RP2D in combination with XELOX or irinotecan in patients with advanced gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Group 1, patients with treatment-naïve recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach.
- •Group 2, patients with recurrent or advanced metastatic gastric cancer including gastroesophageal junction or upper part of the stomach, who were treated ≥2 times with palliative chemotherapy before screening.
- •At least 1 evaluable lesion for the dose escalation part and at least 1 measurable lesion according to RECIST v1.1 for the dose expansion part.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Group 2 Part C, patients should have UGT1A1 genotype tested during or prior to screening.
排除标准
- •Symptomatic central nervous system or uncontrolled brain metastasis
- •Carcinomatous meningitis or its history.
- •For Group 1, patients who are HER 2 positive.
- •Any other concurrent uncontrolled illness including, but not limited to, active or ongoing symptomatic infection requiring IV antibiotic treatment, uncontrolled diabetes, hepatic, renal, or respiratory illness.
- •Severe or unstable angina, myocardial infarction or ischemia, symptomatic congestive heart failure, arterial or venous thromboembolism requiring coronary artery bypass graft or stent within the past 6 months or clinically significant cardiac dysrhythmia or New York Heart Association class II ~ IV heart disease within 6 months of randomization.
- •Uncontrolled hypertension
- •Immunocompromised patients, such as patients known to be serologically positive for HIV.
- •Patients with known active Hepatitis B or C infection.
- •Patients with known active or symptomatic pneumonitis, or history of non-infectious pneumonitis requiring steroids.
- •Diagnosis of a myelodysplastic syndrome/acute myeloid leukemia or its suspicious characteristics.
- •Any unresolved clinically significant Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 toxicity
- •Resting ECG with measurable QTcF > 470 msec on 2 or more time points within a 24-hour period or family history of long QT syndrome.
- •Current use of a cytochrome P3A4 inhibitor or inducer and strong uridine diphosphate (UDP)-glucuronosyltransferase 1A1 (UGT1A1) inhibitors.
研究组 & 干预措施
Group 1
Other
干预措施: IDX-1197+XELOX (Drug)
Group 2
Other
干预措施: IDX-1197+Irinotecan (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
时间窗: through study completion (Up to 12 months)
To determine the MTD and RP2D of IDX-1197 when given in combination with XELOX or Irinotecan. This will be accomplished by the standard 3+3 dose escalation design. If 2 of the 3 to 6 patients in a particular dose level experience a DLT, the dose escalation should be stopped at this dose level, and the MTD will be determined.
Dose Limiting Toxicities (DLTs)
时间窗: during the first 21-day cycle for Group 1 and through first 2 cycles (14 days each) for Group 2
Occurrence of DLTs
次要结局
未报告次要终点
研究者
研究点 (23)
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