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

Phase 1

Recruiting

• Conditions: Gastric Cancer
• Interventions: Drug: IDX-1197+XELOX; Drug: IDX-1197+Irinotecan

• Registration Number: NCT04725994
• Lead Sponsor: Idience Co., Ltd.

Brief Summary

This is an open-label, Phase 1b 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-27
• Study Start: 2021-06-28
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-09-27
• Primary Completion: 2025-09-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 1	IDX-1197+XELOX	-
Group 2	IDX-1197+Irinotecan	-

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (14)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Astera Cancer Care; 🇺🇸 East Brunswick, New Jersey, United States

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

USC Norris Comp. Cancer Ctr Hospital; 🇺🇸 Los Angeles, California, United States

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Hematology Oncology Clinic Baton Rouge / Sarah Cannon; 🇺🇸 Baton Rouge, Louisiana, United States

Beijing Cancer Hospital; 🇨🇳 Beijing, China

The Sixth Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, China

Shanghai East Hospital; 🇨🇳 Shanghai, China

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital - Yonsei Cancer Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of