Phase 2 Stomach Cancer Trial, Recruiting NCT04379596 Sponsor: AstraZeneca Condition: Stomach Cancer
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Phase 2 Stomach Cancer Trial, Recruiting

NCT04379596
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:

  • Adults aged 18 or older (additional age rules may apply depending on local regulations)
  • People who have been diagnosed with a stomach, gastroesophageal junction (GEJ), or esophageal cancer (a specific type called adenocarcinoma) that cannot be surgically removed, has spread locally, or has spread to other parts of the body
  • Depending on which part of the trial is involved, the cancer must have tested either "HER2-positive" or "HER2-low" — these are results from a laboratory test done on tumour tissue that measures a specific protein on cancer cells (confirm with trial site which category applies)
  • For one part of the trial (Part 1), the cancer must have grown or spread after at least one previous treatment that included a medicine called trastuzumab
  • For other parts of the trial (Parts 2–5), the cancer must not have been previously treated for unresectable or metastatic disease
  • The cancer must be measurable on scans using a standard measurement system called RECIST 1.1
  • Blood tests and other assessments must show that the heart, kidneys, liver, and bone marrow are functioning at an adequate level as defined by the trial protocol
  • People who are able to have children must agree to use a highly effective form of contraception, or avoid intercourse, during the trial and after it ends

Who may not be able to join:

  • People with a history of a primary immune system disorder, known HIV (in Parts 1–4), or past or active hepatitis B or C infection (in Parts 1–4); or people with active, uncontrolled HIV, hepatitis B, or hepatitis C (in Part 5)
  • People with another serious illness that is not well controlled
  • People who have a history of lung inflammation not caused by infection (called pneumonitis or interstitial lung disease), currently have this condition, or where this condition cannot be ruled out by scans at the start of the trial
  • People with other serious, clinically significant lung conditions
  • People with an active infection that requires antibiotic, antiviral, or antifungal treatment given directly into a vein (intravenously)
  • People who have a build-up of fluid around the lungs, in the abdomen, or around the heart that requires draining or other procedures to manage it
  • People with spinal cord compression or active cancer that has spread to the brain or central nervous system

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 23 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: 1-877-240-9479

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
Registry
ClinicalTrials.gov
Start date
3 June 2020
Est. completion
1 June 2027

Where this trial is recruiting

🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Part 1: Occurrence of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI CTCAE v5.0; Part 1: Ocurrence of dose-limiting toxicities (DLTs); Part 1: Changes from baseline in laboratory parameters; Part 1: Changes from baseline in vital signs; Part 1: Changes from baseline in electrocardiogram (ECG) results; Part 2, Part 3, Part 4 and Part 5: Endpoint assessed by Investigator per RECIST v1.1: Confirmed 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: 23 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