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RECRUITING Phase 1

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

NCT04725994 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG IDX-1197+XELOX
  • DRUG IDX-1197+Irinotecan

Study Locations (14)

Other

  • Beijing Cancer Hospital — Beijing
  • The Sixth Affiliated Hospital of Sun Yat-Sen University — Guangzhou
  • Shanghai East Hospital — Shanghai
  • Dong-A University Hospital — Busan
  • Seoul National University Bundang Hospital — Seongnam
  • Korea University Anam Hospital — Seoul
  • Asan Medical Center — Seoul
  • Samsung Medical Center — Seoul
  • Seoul National University Hospital — Seoul
  • Severance Hospital - Yonsei Cancer Center — Seoul

California

  • USC Norris Comp. Cancer Ctr Hospital — Los Angeles

Louisiana

  • Hematology Oncology Clinic Baton Rouge / Sarah Cannon — Baton Rouge

Massachusetts

  • Dana Farber Cancer Institute — Boston

New Jersey

  • Astera Cancer Care — East Brunswick

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2021-06-28
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

Idience Co.

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04725994

The ClinicalTrials.gov registry entry for NCT04725994 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Idience Co., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Gastric Cancer appearing as the primary indexed condition, and to 2 interventions — of which IDX-1197+XELOX is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04725994 reports 14 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04725994 about?

NCT04725994 is a clinical study titled "Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX 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.

What is the current status of trial NCT04725994?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2021-06-28. Estimated completion is 2026-06-30.

What conditions does trial NCT04725994 study?

This clinical trial studies the following conditions: Gastric Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04725994?

The interventions under investigation include: IDX-1197+XELOX (DRUG), IDX-1197+Irinotecan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04725994?

This trial is sponsored by Idience Co., which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04725994 being conducted?

This trial has 14 study locations across California, Louisiana, Massachusetts, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial