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

NCT04725994 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ID-VDP-103
• Study Type: interventional
• Target: 87
• Locations: 3 countries
• Sites: 17

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.

Conditions

Gastric Cancer

Keywords

1197; IDX-1197; venadaparib

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group 1

OTHER

Drug: IDX-1197+XELOX

Group 2

OTHER

Drug: IDX-1197+Irinotecan

Interventions

IDX-1197+XELOX DRUG

The dose levels will be escalated following a 3+3 dose escalation scheme.

Group 1

IDX-1197+Irinotecan DRUG

The dose levels will be escalated following a 3+3 dose escalation scheme.

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idience Co., Ltd.: lead

Study Sites (17)

USC Norris Comp. Cancer Ctr Hospital

Los Angeles, California, 90033, United States

Location

Hematology Oncology Clinic Baton Rouge / Sarah Cannon

Baton Rouge, Louisiana, 70809, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

Location

Beijing Cancer Hospital

Beijing, China

Location

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China

Location

Shanghai East Hospital

Shanghai, China

Location

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital - Yonsei Cancer Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 27, 2021
• Study Start: June 28, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

KR (9); US (5); CN (3)