Status:
RECRUITING
Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX or Irinotecan in Patients with Advanced Gastric Cancer
Lead Sponsor:
Idience Co., Ltd.
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ca...
Eligibility Criteria
Inclusion
- 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.
- Group 2 Part C, patients should have UGT1A1 genotype tested during or prior to screening.
Exclusion
- 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.
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04725994
Start Date
June 28 2021
End Date
June 30 2026
Last Update
September 27 2024
Active Locations (14)
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1
USC Norris Comp. Cancer Ctr Hospital
Los Angeles, California, United States, 90033
2
Hematology Oncology Clinic Baton Rouge / Sarah Cannon
Baton Rouge, Louisiana, United States, 70809
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
Astera Cancer Care
East Brunswick, New Jersey, United States, 08816