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OncoMatch/Clinical Trials/NCT04725994

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

Is NCT04725994 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including IDX-1197+XELOX and IDX-1197+Irinotecan for gastric cancer.

Phase 1/2RecruitingIdience Co., Ltd.NCT04725994Data as of May 2026

Treatment: IDX-1197+XELOX · IDX-1197+IrinotecanThis 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.

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Extracted eligibility criteria

Cancer type

Gastric Cancer

Biomarker criteria

Required: UGT1A1 any tested

Group 2 Part C, patients should have UGT1A1 genotype tested during or prior to screening

Excluded: HER2 (ERBB2) any tested

For Group 1, patients who are HER 2 positive [excluded]

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: palliative chemotherapy — palliative

Group 2, patients...who were treated ≥2 times with palliative chemotherapy before screening

Lab requirements

Kidney function

no uncontrolled renal illness

Liver function

no uncontrolled hepatic illness

Cardiac function

no 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 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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • USC Norris Comp. Cancer Ctr Hospital · Los Angeles, California
  • Hematology Oncology Clinic Baton Rouge / Sarah Cannon · Baton Rouge, Louisiana
  • Dana Farber Cancer Institute · Boston, Massachusetts
  • Astera Cancer Care · East Brunswick, New Jersey

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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