Phase 2 Stomach Cancer Trial, Recruiting NCT05523947 Sponsor: Yuhan Corporation Condition: Stomach Cancer
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Phase 2 Stomach Cancer Trial, Recruiting

NCT05523947
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For the Dose Escalation part of the trial:

  • People whose cancer has been confirmed by laboratory testing to be HER2-positive (a specific protein found on some cancer cells)
  • People who are able to provide a sample of their tumor tissue

For the Dose Expansion part of the trial:

  • People who have at least one tumor that can be measured on a scan
  • People who are able to provide a sample of their tumor tissue
  • Cohort 1: People with HER2-positive cancer of the biliary tract (the tubes that carry bile from the liver), confirmed by laboratory testing
  • Cohort 2: People with HER2-positive cancer that has spread to other parts of the body, where the cancer type is not breast cancer, stomach cancer, gastroesophageal junction cancer, or biliary tract cancer, confirmed by laboratory testing

Who may not be able to join:

  • People whose cancer has spread to the brain or central nervous system in a way that is not under control
  • People with compression or pressure on the spinal cord caused by cancer
  • People with cancer that has spread to the membranes surrounding the brain and spinal cord
  • People who have recently experienced a heart attack or related acute heart condition
  • People with heart failure
  • People with a condition causing scarring or inflammation in the lung tissue (interstitial lung disease)
  • People with inflammation of the lungs (pneumonitis)
  • People who have previously had a second, separate type of cancer
  • People living with HIV
  • People with active, ongoing hepatitis B infection
  • People with hepatitis C infection
  • People currently taking steroid medications that affect the whole body
  • People with an autoimmune disease (where the immune system attacks the body's own tissues)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Hyejin Choi, Severance Hospital

Phone: +82-2-828-0065

Australian sites

Southern Oncology Clinical Research Unit, Adelaide,
Austin Health, Melbourne,
Breast Cancer Research Centre - WA, Perth,
Blacktown Hospital, Sydney,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Yuhan Corporation
Registry
ClinicalTrials.gov
Start date
26 August 2022
Est. completion
31 March 2028

Where this trial is recruiting

🇦🇺 Australia 🇰🇷 South Korea 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Treatment-emergent adverse events (TEAEs) up to Day 21; Objective Response Rate (ORR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov