Phase 1 Stomach Cancer Trial, Recruiting NCT06663319 Sponsor: Janssen Research & Development, LLC Condition: Stomach Cancer
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Phase 1 Stomach Cancer Trial, Recruiting

NCT06663319
Recruiting Phase 1

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:

  • You have been diagnosed with colorectal cancer (confirmed by a tissue or cell sample) that has spread or cannot be removed by surgery, and it has continued to grow after receiving standard treatments (the exact number of prior treatments required depends on which part of the trial you would join)
  • If joining the stomach/esophageal cancer arm (Arm E), you have been diagnosed with stomach cancer or cancer at the junction of the stomach and food pipe that has spread or cannot be removed, and it has continued to grow after at least one prior standard treatment
  • Your cancer can be measured or assessed on scans (at least one measurable area of cancer is required for most parts of the trial)
  • You are generally well enough to carry out everyday activities with little or no limitation (this is measured on a standard scale called ECOG, scores 0–1)
  • Your kidneys are working at an acceptable level, based on a standard blood test measuring kidney function

Who may not be able to join:

  • You have cancer that has spread to the brain and is new or getting worse, has spread to the membranes surrounding the brain or spinal cord, or you have untreated pressure on the spinal cord
  • You still have significant side effects from previous cancer treatments that have not mostly resolved (with some exceptions, such as hair loss, certain nerve-related symptoms, or stable hormone-related conditions — confirm with trial site)
  • You have or have had another cancer at the same time, unless it is very unlikely to affect the trial results or your safety (confirm with trial site)
  • You have taken steroid medications (such as prednisone) at doses above 10 mg per day within the 7 days before starting the trial drug
  • You have received or plan to receive a live vaccine within 4 weeks before starting the trial drug or within 4 weeks after your last dose

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 6 July 2026
Phase 1: approximately ~10% 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: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Phone: 844-434-4210

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 1
Registry
ClinicalTrials.gov
Start date
15 October 2024
Est. completion
25 February 2028

Where this trial is recruiting

🇰🇷 South Korea 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity; Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)

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: 6 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