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

Study Overview

• Status: Active, not recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: IDX-1197+XELOX; Drug: IDX-1197+Irinotecan

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Cancer Hospital
  • Guangzhou, China
    • The Sixth Affiliated Hospital of Sun Yat-Sen University
  • Shanghai, China
    • Shanghai East Hospital
• South Korea
  • Busan, South Korea, 49201
    • Dong-A University Hospital
  • Seongnam, South Korea
    • Seoul National University Bundang Hospital
  • Seoul, South Korea
    • Asan Medical Center
  • Seoul, South Korea
    • Samsung Medical Center
  • Seoul, South Korea
    • Seoul National University Hospital
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Seoul, South Korea
    • Severance Hospital - Yonsei Cancer Center
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, South Korea
      • Jeonbuk National University Hospital
• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Norris Comp. Cancer Ctr Hospital
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Hematology Oncology Clinic Baton Rouge / Sarah Cannon
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Astera Cancer Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1	Drug: IDX-1197+XELOX; The dose levels will be escalated following a 3+3 dose escalation scheme.
Other: Group 2	Drug: IDX-1197+Irinotecan; The dose levels will be escalated following a 3+3 dose escalation scheme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)	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.	through study completion (Up to 12 months)
Dose Limiting Toxicities (DLTs)	Occurrence of DLTs	during the first 21-day cycle for Group 1 and through first 2 cycles (14 days each) for Group 2

Collaborators and Investigators

• Sponsor: Idience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: 1197; venadaparib; IDX-1197
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Irinotecan
• Other Study ID Numbers: ID-VDP-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No