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IDX-1197 + Chemotherapy for Stomach Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Idience Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (up to 12 months)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug for safety and how well it works with other drugs to treat advanced gastric cancer.

Who is the study for?
This trial is for adults with advanced gastric cancer, including tumors at the gastroesophageal junction or upper stomach. Group 1 includes those who haven't had treatment before, while Group 2 has had two or more rounds of chemotherapy. Participants must be relatively healthy and active (ECOG ≤1) and have at least one measurable tumor. People with HIV, hepatitis B/C, heart issues, uncontrolled illnesses like diabetes or infections needing IV antibiotics can't join.
What is being tested?
The study tests IDX-1197 in combination with either XELOX (a mix of capecitabine and oxaliplatin) or irinotecan to see how safe they are together and to find the best doses for treating advanced gastric cancer. It's an early-phase trial where everyone knows what treatment they're getting (open-label).
What are the potential side effects?
Potential side effects include typical reactions from chemotherapy such as nausea, vomiting, diarrhea, fatigue, low blood counts leading to increased infection risk or bleeding problems. IDX-1197 may also have its own unique side effects which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced stomach cancer and have had at least 2 rounds of chemotherapy.
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I am fully active or can carry out light work.
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I have advanced or recurrent stomach cancer that has not been treated yet.
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I have at least one tumor that can be measured or evaluated.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have no ongoing major side effects from previous treatments.
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My heart's electrical activity is abnormal, or I have a family history of long QT syndrome.
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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
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My high blood pressure is not under control.
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I do not have any uncontrolled illnesses like severe infections, diabetes, or liver, kidney, or lung diseases.
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I am not taking any strong medication that affects liver enzymes.
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I have had cancer spread to the lining of my brain and spinal cord.
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I haven't had serious heart issues or surgeries in the last 6 months.
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I have an active Hepatitis B or C infection.
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I am HER2 positive.
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I have symptoms from brain metastasis that are not under control.
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I do not have active or symptomatic pneumonitis, nor a history of it requiring steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (up to 12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (up to 12 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose Limiting Toxicities (DLTs)
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Group II: Group 1Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Idience Co., Ltd.Lead Sponsor
3 Previous Clinical Trials
177 Total Patients Enrolled

Media Library

IDX-1197 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04725994 — Phase 1 & 2
Stomach Cancer Research Study Groups: Group 2, Group 1
Stomach Cancer Clinical Trial 2023: IDX-1197 Highlights & Side Effects. Trial Name: NCT04725994 — Phase 1 & 2
IDX-1197 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04725994 — Phase 1 & 2
~18 spots leftby Sep 2025
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