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NCT04725994 | RECRUITING | Gastric Cancer

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

Idience Co., Ltd.

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 cancer.

Condition or disease

Gastric Cancer

Intervention/treatment

IDX-1197+XELOX

IDX-1197+Irinotecan

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Open-Label, International, Multicenter, Phase 1b/2a Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX (Capecitabine and Oxaliplatin) or Irinotecan in Patients with Advanced Gastric Cancer
Actual Study Start Date : 2021-06-28
Estimated Primary Completion Date : 2025-09-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX or Irinotecan in Patients with Advanced Gastric Cancer

Location Details

NCT04725994

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

USC Norris Comp. Cancer Ctr Hospital

Los Angeles, California, United States, 90033

NOT YET RECRUITING

United States, Louisiana

Hematology Oncology Clinic Baton Rouge / Sarah Cannon

Baton Rouge, Louisiana, United States, 70809

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, New Jersey

ASSRACE CANCER which

East Brunswick, New Jersey, United States, 08816

NOT YET RECRUITING

China,

Beijing Cancer Hospital

Beijing, China,

NOT YET RECRUITING

China,

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China,

NOT YET RECRUITING

China,

Shanghai East Hospital

Shanghai, China,

NOT YET RECRUITING

Korea, Republic of,

Dong-A University Hospital

Busan, Korea, Republic of, 49201

RECRUITING

Korea, Republic of,

Seoul National University Bundang Hospital

Seongnam, Korea, Republic of,

RECRUITING

Korea, Republic of,

Korea University Anam Hospital

Seoul, Korea, Republic of, 02841

RECRUITING

Korea, Republic of,

Asan Medical Center

Seoul, Korea, Republic of,

RECRUITING

Korea, Republic of,

Samsung Medical Center

Seoul, Korea, Republic of,

RECRUITING

Korea, Republic of,

Seoul National University Hospital

Seoul, Korea, Republic of,

RECRUITING

Korea, Republic of,

Severance Hospital - Yonsei Cancer Center

Seoul, Korea, Republic of,