Phase 2 Oesophageal Cancer Trial, Recruiting NCT06324357 Sponsor: Boehringer Ingelheim Condition: Oesophageal Cancer
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Phase 2 Oesophageal Cancer Trial, Recruiting

NCT06324357
Recruiting Phase 2

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:

  • People aged 18 or older (or the legal age of consent in their country) at the time of signing the consent form.
  • People with a confirmed diagnosis of HER2-positive metastatic breast cancer, or metastatic cancer of the stomach, gastroesophageal junction, or esophagus (for most groups in the trial).
  • People with metastatic colorectal cancer that has been confirmed as HER2-positive through standard testing guidelines (for specific groups in the trial).
  • People who are able to provide a tumor tissue sample from an area that has not been previously treated with radiation, if possible (for the Phase II part of the trial).
  • People who have already received certain prior cancer treatments and whose disease has continued to grow or spread despite those treatments (the specific treatments required vary depending on which group a person would join — confirm with trial site).
  • People who have at least one measurable area of disease that can be tracked on scans, according to standard measurement criteria.
  • People with a good general level of physical functioning, rated 0 or 1 on a standard scale used by doctors (meaning fully active or able to carry out light activity).
  • People with adequately functioning organs, based on recent blood test results.

Who may not be able to join:

  • People in certain trial groups who have previously been treated with a small molecule HER2-blocking drug, a drug called T-DXd (trastuzumab deruxtecan), a drug called T-DM1 (trastuzumab emtansine), or a drug called capecitabine — the specific restrictions depend on which group applies (confirm with trial site).
  • People who have brain metastases (cancer that has spread to the brain) that are active or causing symptoms, or disease affecting the lining around the brain and spinal cord.
  • People whose heart's electrical activity shows a prolonged QT interval above a specific threshold on a resting heart tracing (confirm with trial site).
  • People who have conditions that increase the risk of abnormal heart rhythms, such as heart failure, low potassium levels, a condition called long QT syndrome (either personal or inherited), or a family history of unexplained sudden death in someone under 40 years of age.
  • People whose heart pumping function (ejection fraction) is below 50%, or below the normal range used by the testing facility, as measured within 28 days before joining the trial.
  • People who have a history of non-infectious lung inflammation (interstitial lung disease or pneumonitis) that required steroid treatment, who currently have this condition, or where this condition cannot be ruled out based on scans done at the start of the trial.

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 21 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

Phone: 1-800-243-0127

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
Registry
ClinicalTrials.gov
Start date
3 June 2024
Est. completion
8 January 2029

Where this trial is recruiting

🇧🇪 Belgium 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period; Dose optimization and justification (Phase II): Objective response (OR)

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: 21 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