MedTrace Logo

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

NCT04725994 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2026-04-17

No results posted yet for this 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.

Conditions

Interventions

DRUG

IDX-1197+XELOX

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

DRUG

IDX-1197+Irinotecan

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

Sponsors & Collaborators

  • Idience Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2026-07-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States
  • China
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04725994 on ClinicalTrials.gov