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)
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) — through study completion (Up to 12 months) To determine the MTD and RP2D of IDX-1197 when given in combination with XELOX or Irinotecan. This will be accomplished by the standard 3+3 dose escalation design. If 2 of the 3 to 6 patients in a particular dose level experience a DLT, the dose escalation should be stopped at this dose level, and the MTD will be determined.
Dose Limiting Toxicities (DLTs) — during the first 21-day cycle for Group 1 and through first 2 cycles (14 days each) for Group 2 Occurrence of DLTs
Trial sites (17)
Facility
City
Region
Status
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
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.
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