Phase 1 Stomach Cancer Trial, Recruiting NCT07114601 Sponsor: Eli Lilly and Company Condition: Stomach Cancer
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Phase 1 Stomach Cancer Trial, Recruiting

NCT07114601
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:

  • People who have been confirmed through a tissue or cell sample to have locally advanced, inoperable, or cancer that has spread to other parts of the body.
  • People whose scans (CT or MRI) show at least one measurable tumour, or — if only bone involvement is present — at least two active bone lesions confirmed by a bone scan or MRI.
  • People whose cancer tests positive for a specific protein marker called GRPR, as assessed through specialised imaging.
  • People diagnosed with one of the following specific cancer types: certain types of breast cancer (ER-positive/HER2-negative or ER-positive/HER2-positive), squamous cell carcinoma of the oesophagus, adenocarcinoma of the stomach, gastroesophageal junction, or oesophagus, colorectal cancer, prostate cancer that has spread and no longer responds to hormone treatment, certain types of endometrial (uterine lining) cancer (note: some subtypes such as uterine leiomyosarcoma, adenosarcoma, and endometrial stromal sarcoma are not eligible), low-grade papillary serous ovarian cancer, or other solid tumours (not originating in the brain or spinal cord) that test positive for GRPR, in specific trial groups only.
  • People with breast cancer whose ER and HER2 status has been tested from the most recent tissue sample taken when the cancer returned or spread, where this is possible.
  • People with a general health and activity level rated at 0 or 1 on a standard medical scale (ECOG), meaning someone who is fully active or has some limitations in strenuous activity but can carry out light work (confirm with trial site).
  • People who are able to attend outpatient appointments, undergo regular blood tests and scans, and attend required clinic visits for the full duration of the trial.

Who may not be able to join:

  • People in the early phase of the trial (specific dose groups) who have previously received radioactive drug therapies — though for prostate cancer, prior treatment with a specific radioactive therapy called ¹⁷⁷Lu-PSMA may be permitted (confirm with trial site).
  • People who have had acute pancreatitis (sudden severe inflammation of the pancreas) at any point in the past year.
  • People who have previously received radiation treatment covering more than a quarter of their bone marrow, or who have had half-body or whole-body radiotherapy.
  • People whose bone scan shows a pattern called a "superscan," where very high uptake is seen across the skeleton (confirm with trial site).
  • People who have an untreated urinary tract blockage or urinary leakage that cannot be managed.
  • People with active Hepatitis B virus (HBV) infection — though people with chronic HBV may still be considered if they meet specific conditions around antiviral treatment and virus levels (confirm with trial site).
  • People with active Hepatitis C virus (HCV) infection — though people who have previously been treated for HCV and meet specific conditions around virus levels may still be considered (confirm with trial site).
  • People with untreated HIV — though people with well-controlled HIV on a stable treatment regimen who meet specific conditions around virus levels and immune cell counts may still be considered (confirm with trial site).
  • People who have a second active cancer, unless it has been in remission with a life expectancy of more than two years.
  • People who have a known allergy or sensitivity to any ingredient in the trial drug LY4257496.

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 27 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: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Phone: 1-317-615-4559

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
6 August 2025
Est. completion
1 April 2030

Where this trial is recruiting

🇨🇦 Canada 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇯🇵 Japan 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496; Phase 1a Dose Optimization: Number of Dose Limiting Toxicities of LY4257496; Phase 1b Dose Expansion and Optimization: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)

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: 27 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