Phase 1 Stomach Cancer Trial, Recruiting NCT06441331 Sponsor: ITM Solucin GmbH Condition: Stomach Cancer
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Phase 1 Stomach Cancer Trial, Recruiting

NCT06441331
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:

  • Children and young people aged 2 years old up to (but not including) 18 years old
  • People who have a confirmed diagnosis of a tumour that tests positive for a specific protein called the somatostatin receptor (SSTR)
  • People whose tumour has come back or has stopped responding to at least one previous cancer treatment
  • People whose tumour tissue sample has confirmed SSTR protein, shown through a laboratory test on a biopsy or surgical sample
  • People whose tumour shows a certain level of radioactive uptake on a specific type of scan (SPECT/CT or PET/CT), measured as higher than the uptake seen in the liver (confirm with trial site)
  • People who have recovered from the side effects of previous cancer treatments before joining the trial (most side effects must be mild or resolved, with some specific exceptions such as hair loss or stable, treated hormone or electrolyte issues)
  • People who have completed a required waiting period after previous treatments before starting the trial treatment (confirm with trial site for timing details)
  • A parent or legal guardian must be willing to sign a screening consent form, and the young person's own agreement (assent) will also be sought where appropriate

Who may not be able to join:

  • People with a known allergy or sensitivity to Lutetium Lu 177 Edotreotide or its related components
  • People with a previous history of acute leukaemia, unless it has been in remission for at least two years
  • People with extensive cancer involvement in the bones or bone marrow, unless a sufficient supply of stem cells is available and stored
  • People who have previously received a systemic targeted radiation therapy of the same type used in this trial
  • People who have previously received a treatment called MIBG, if the total radiation dose to the bone marrow or kidneys would exceed certain safety limits
  • People who have previously received external beam radiation therapy, if the total radiation dose to the bone marrow or kidneys would exceed certain safety limits
  • People who have previously received an immune cancer vaccine or a treatment called CAR-T cell therapy
  • People with a large volume of tumour spread within the brain or spinal cord area
  • People with serious problems affecting the kidneys, liver, heart, blood, or electrolyte levels
  • People who have received a live-attenuated vaccine (a type of vaccine made with a weakened live virus or bacteria) within four weeks before joining the trial
  • People who are pregnant or breastfeeding
  • People with another known cancer diagnosis
  • People with a serious non-cancer illness

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 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: Roman Henkel, PhD, Director, Global Clinical Operations

Phone: +4989 32989866000

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
Sponsor
ITM Solucin GmbH
Registry
ClinicalTrials.gov
Start date
26 September 2025
Est. completion
1 June 2028

Where this trial is recruiting

🇫🇷 France 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Pediatric Dosage

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