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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Gastric Cancer

In brief

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.

Key facts

Study ID

NCT04725994

Run by

Idience Co., Ltd.

People needed

87

Starts

2021-06-28

Expected to finish

2027-03-31

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC Norris Comp. Cancer Ctr Hospital — Los Angeles, California, United States
• Hematology Oncology Clinic Baton Rouge / Sarah Cannon — Baton Rouge, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Astera Cancer Care — East Brunswick, New Jersey, United States
• 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, South Korea
• 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

Full record on ClinicalTrials.gov

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