Early Phase 1 Stomach Cancer Trial, Recruiting NCT07595237 Sponsor: SmartNuclide Biopharma Condition: Stomach Cancer
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Early Phase 1 Stomach Cancer Trial, Recruiting

NCT07595237
Recruiting Early 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 are between 18 and 75 years old (inclusive)
  • You are able to make your own decisions and are willing to sign a consent form to take part voluntarily
  • You are generally able to carry out light activity and care for yourself (a standard fitness scale called ECOG rates you as 0 or 1)
  • Your doctors expect you to live for more than 6 months
  • You have been diagnosed with an advanced solid tumour — such as stomach cancer, cancer at the junction of the stomach and food pipe, pancreatic cancer, or bile duct cancer — confirmed by a tissue or cell sample, and your cancer has not responded to first-line treatment or has gotten worse
  • You have at least one tumour that can be measured using standard imaging methods
  • Your tumour tests positive for a protein called Claudin18.2 on at least 20% of tumour cells at a certain level of intensity (confirm with trial site)
  • Any side effects from previous treatments have mostly settled down before starting this trial
  • Your bone marrow, liver, kidney, and blood clotting functions meet specific healthy ranges as tested by blood tests within one week before starting treatment (confirm exact values with trial site)
  • If you or your partner could become pregnant, you must be willing to use reliable contraception during the study and for 6 months after the last dose

Who may not be able to join:

  • You are very underweight (BMI below 18.5) and your doctors feel you would not cope with the treatment
  • You have previously had an allergic reaction to the study drug (177Lu-DOTA-SNA040) or similar drugs
  • You have received radioactive isotope-based treatments (such as those using lutetium-177 or similar) within the past 4 weeks
  • You have received a type of cancer drug called an antibody-drug conjugate (ADC) within the past 4 weeks
  • You have taken part in another experimental cancer treatment trial within the past 4 weeks
  • You have cancer that has spread to your brain or the lining around your brain or spinal cord
  • You have serious heart problems (such as severe heart failure), a known inherited condition affecting heart rhythm, an active serious infection, or another major health condition the doctors consider unsafe for participation
  • You have significant stomach bleeding or an untreated stomach ulcer
  • You have been diagnosed with another type of cancer that could affect your life expectancy or make it harder to assess your condition
  • You are pregnant or breastfeeding
  • The trial doctors have another reason they feel you would not be suitable to participate (confirm with trial site)

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
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Phone: 0512-67229125

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
Early Phase 1
Sponsor
SmartNuclide Biopharma
Registry
ClinicalTrials.gov
Start date
1 November 2025
Est. completion
24 November 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Dose-limiting toxicity(DLT) of the single dose; The safety and tolerance of 177Lu-DOTA-SNA040; The safety and tolerance of 177Lu-DOTA-SNA040; The safety and tolerance of 177Lu-DOTA-SNA040; The safety and tolerance of 177Lu-DOTA-SNA040; The safety and tolerance of 177Lu-DOTA-SNA040

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