An Open-Label, International, Multicenter, Phase 1b 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
Description
Brief Summary
This is an open-label, Phase 1b 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.
Phase
N/AInclusion and Exclusion Criteria
- 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 ≤1.
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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