🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT04725994
Active, not recruiting Phase 1/2

Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX or Irinotecan in Patients With Advanced Gastric Cancer

NCT04725994 · tracked via the Priya Life Science China tracker
Sponsor
Idience Co., Ltd.
Phase
Phase 1/2
Started
2021-06-28
Last updated
2026-04-17

Condition(s) studied

Gastric Cancer

Investigational drug(s) / intervention(s)

IDX-1197+XELOX →IDX-1197+Irinotecan →

IDX-1197+XELOX: The dose levels will be escalated following a 3+3 dose escalation scheme.

IDX-1197+Irinotecan: The dose levels will be escalated following a 3+3 dose escalation scheme.

Study 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 cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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. * Group 2 Part C, patients should have UGT1A1 genotype tested during or prior to screening. 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.

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
USC Norris Comp. Cancer Ctr Hospital Los Angeles California
Hematology Oncology Clinic Baton Rouge / Sarah Cannon Baton Rouge Louisiana
Beth Israel Deaconess Medical Center Boston Massachusetts
Dana Farber Cancer Institute Boston Massachusetts
Astera Cancer Care East Brunswick New Jersey
Beijing Cancer Hospital Beijing China
The Sixth Affiliated Hospital of Sun Yat-Sen University Guangzhou China
Shanghai East Hospital Shanghai China
Jeonbuk National University Hospital Jeonju Jeollabuk-do
Dong-A University Hospital Busan South Korea
Seoul National University Bundang Hospital Seongnam South Korea
Korea University Anam Hospital Seoul South Korea
Korea University Guro Hospital Seoul South Korea
Asan Medical Center Seoul South Korea
Samsung Medical Center Seoul South Korea
Seoul National University Hospital Seoul South Korea
Severance Hospital - Yonsei Cancer Center Seoul South Korea

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04725994 on ClinicalTrials.gov ↗ ← All trials in China