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New drug combo shows promise in early stomach cancer trial

NCT ID NCT04725994

Disease control Sponsor: Idience Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a new drug called IDX-1197 combined with standard chemotherapy (XELOX or irinotecan) in 87 people with advanced stomach cancer. The main goal is to find the safest dose and check for side effects. It is not yet known if the combination works better than current treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IDX-1197 (a drug) combined with chemotherapy (capecitabine, oxaliplatin, or irinotecan)
What this could lead to
If it works, this could point toward a new treatment option for advanced gastric cancer that may help control the disease.
What could go wrong
This is an early-phase trial with only 87 patients, so it is too small to prove effectiveness. The drug may cause side effects or fail to improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

87 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

gastric cancer gastric neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, South Korea

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816, United States

  • Beijing Cancer Hospital

    Beijing, China

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dong-A University Hospital

    Busan, 49201, South Korea

  • Hematology Oncology Clinic Baton Rouge / Sarah Cannon

    Baton Rouge, Louisiana, 70809, United States

  • Jeonbuk National University Hospital

    Jeonju, Jeollabuk-do, South Korea

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seongnam, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital - Yonsei Cancer Center

    Seoul, South Korea

  • Shanghai East Hospital

    Shanghai, China

  • The Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, China

  • USC Norris Comp. Cancer Ctr Hospital

    Los Angeles, California, 90033, United States

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