Assessing IDX-1197 with chemotherapy for advanced gastric cancer
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
This study is testing a new drug called IDX-1197 combined with chemotherapy to see if it is safe and effective for people with advanced gastric cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Idience Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 14 sites (Los Angeles, California and 13 other locations) |
| Trial ID | NCT04725994 on ClinicalTrials.gov |
What this trial studies
This open-label Phase 1b/2a study evaluates the safety and tolerability of IDX-1197 when combined with either XELOX or irinotecan in patients with advanced gastric cancer. The study aims to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for these combinations. Patients will be monitored for efficacy and safety outcomes throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include patients with treatment-naïve or previously treated advanced gastric cancer who meet specific inclusion criteria.
Not a fit: Patients with symptomatic central nervous system metastasis or those who are HER2 positive may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced gastric cancer.
How similar studies have performed: Other studies have explored similar combinations in gastric cancer, but the specific use of IDX-1197 is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California and 13 other locations
- USC Norris Comp. Cancer Ctr Hospital — Los Angeles, California, United States (Recruiting)
- Hematology Oncology Clinic Baton Rouge / Sarah Cannon — Baton Rouge, Louisiana, United States (Not_yet_recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Astera Cancer Care — East Brunswick, New Jersey, United States (Recruiting)
- Beijing Cancer Hospital — Beijing, China (Not_yet_recruiting)
- The Sixth Affiliated Hospital of Sun Yat-Sen University — Guangzhou, China (Not_yet_recruiting)
- Shanghai East Hospital — Shanghai, China (Not_yet_recruiting)
- Dong-A University Hospital — Busan, Korea, Republic of (Not_yet_recruiting)
- Seoul National University Bundang Hospital — Seongnam, Korea, Republic of (Recruiting)
- Korea University Anam Hospital — Seoul, Korea, Republic of (Recruiting)
- Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- Severance Hospital - Yonsei Cancer Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Won Sik Lee
- Email: wonsiklee@idience.com
- Phone: 8225263622
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.