Phase 1 Stomach Cancer Trial, Recruiting NCT06617169 Sponsor: Monopar Therapeutics Condition: Stomach Cancer
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Phase 1 Stomach Cancer Trial, Recruiting

NCT06617169
Recruiting Phase 1 🇦🇺 Australian site

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 previously took part in the MNPR-101-D001 study.
  • Women who could become pregnant must have a negative pregnancy blood test at the screening visit, and a negative pregnancy urine test on the first day of treatment if screening took place more than 7 days earlier.
  • Both men and women must agree to use highly effective birth control during the treatment period and for up to 3 months after the last dose, if there is any possibility of pregnancy.
  • Women who are currently breastfeeding must agree to stop breastfeeding before receiving the study drug, and must not breastfeed for 3 months after the last dose.

Who may not be able to join:

  • People who received chemotherapy, radiation therapy (other than a short course of palliative radiation), or immunotherapy within 14 days before receiving the study drug.
  • People who are still experiencing significant side effects (graded as severe or higher) from a previous cancer treatment.
  • People who received any radioactive drug treatment or other experimental treatment within 4 weeks or 5 half-lives (whichever is longer) before the first dose, except for a specific imaging agent used in the earlier study (MNPR-101-DFO*-89Zr).
  • People whose blood test results at screening show poor bone marrow function, such as low platelet counts, low white blood cell counts, or low haemoglobin levels (including those who have received a red blood cell transfusion in the past 4 weeks).
  • People whose blood test results show that the liver is not working well enough, based on specific enzyme and bilirubin level thresholds (confirm with trial site).
  • People whose kidney function is too low, based on a specific kidney function calculation (confirm with trial site).
  • People who experienced a serious blood-related or liver-related side effect during the earlier MNPR-101-D001 study that was linked to the study treatment.
  • People whose earlier study results show that the radiation dose their organs would receive is too high to be considered safe, as assessed by the study sponsor.
  • People with other serious non-cancer illnesses affecting the kidneys, liver, or blood that could interfere with the study, as judged by the study doctor.
  • People who have cognitive difficulties or other conditions that may prevent them from giving informed consent or following the study requirements.

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 20 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

Phone: 847-794-8435

Australian sites

Melbourne Theranostic Innovation Centre (MTIC), North Melbourne, Victoria
03 9454 5800

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
Monopar Therapeutics
Registry
ClinicalTrials.gov
Start date
8 October 2024
Est. completion
1 December 2026

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Identify the dose-limiting toxicities (DLTs) of fractionated MNPR-101-PCTA-177Lu dosing and their frequency; Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of fractionated MNPR-101-PCTA-177Lu dosing

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: 20 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