Description:
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.
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.
Recruiting
Phase 1
Drug | Synonyms | Arms |
---|---|---|
IDX-1197+XELOX | Group 1 | |
IDX-1197+Irinotecan | Group 2 |
Name | Type | Description | Interventions |
---|---|---|---|
Group 1 | Other |
| |
Group 2 | Other |
|
Inclusion 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. Exclusion Criteria: - 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) |
Time Frame: | through study completion (Up to 12 months) |
Safety Issue: | |
Description: | 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. |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Idience Co., Ltd. |
August 25, 2021