New radiation drug targets Hard-to-Treat cancers in early trial
NCT ID NCT07595237
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This early-stage study tests a new drug (177Lu-DOTA-SNA040) that delivers radiation directly to cancer cells with a specific marker (Claudin 18.2). It is for people with advanced stomach, pancreatic, or bile duct cancers that have worsened after standard treatment. The main goals are to check safety, find the right dose, and see if the drug reaches tumors. Only 12 participants will be enrolled.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age range of 18 to 75 years old (including boundary values); 2. Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF); 3. Individuals with ECOG scores ranging from 0 to 1 (see Appendix 1 for details); 4. Life expectancy\>6 months; 5. Patients with advanced solid tumors confirmed by histopathology or cytology (such as gastric cancer or adenocarcinoma at the gastroesophageal junction, pancreatic cancer, and cholangiocarcinoma) and confirmed by the investigator, who fail to receive first-line treatment or have disease progression; According to RECIST 1.1 definition, there must be at least one measurable lesion; 7\. At least one lesion must be immunohistochemistry positive for Claudin18.2 (≥ 20% of tumor cells have Claudin18.2 immunohistochemistry membrane staining intensity ≥ 2+); Before the first administration of 177Lu-DOTA-SNA040 treatment, the toxicity caused by previous treatments must be restored to ≤ level 2 (CTCAE V5.0) or a stable state evaluated by the researcher (excluding hair loss and pigmentation); 177Lu DOTA-SNA040 has sufficient organ function one week before treatment, defined as follows: 1. Bone marrow: White blood cell count range from 3.0 to 10.0 × 10\^9/L Absolute neutrophil count range from 1.5 to 7.0 × 10\^9/L Platelets range from 75 to 300 × 10\^9/L Hemoglobin ≥ 90g/L 2. Liver: Total bilirubin ≤ 2.5 x upper limit of normal (ULN) Serum albumin\>3.0 g/dL Alanine aminotransferase and aspartate aminotransferase ≤ 3 × ULN or liver metastasis patients ≤ 5 × ULN 3. Kidney: Serum/plasma creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (calculated using the Cockcroft Gault formula) 4. Coagulation function The international standardized ratio of prothrombin is less than 1.5 × ULN Prothrombin time\<2 × ULN During the treatment with 177Lu-DOTA-SNA040, the best support/standard of care agreed upon by the researcher is allowed; 11. Patients and/or partners with fertility must use adequate contraceptive measures during the study period and within 6 months after the last administration of the study drug. Exclusion Criteria: 1. The nutritional status is extremely poor, with a BMI of less than 18.5 during screening, and the subjects cannot tolerate the test; 2. Individuals who have previously been allergic to 177Lu DOTA-SNA040 or its analogues; 3. Patients who have received therapeutic drugs and radiation therapy labeled with 177Lu and other radioactive isotopes 4 weeks before treatment with 177Lu DOTA-SNA040; 4. 177Lu DOTA-SNA040 patients who received antibody conjugated drug (ADC) treatment 4 weeks before treatment; 5. Those who have received other experimental anti-tumor drug treatments 4 weeks before 177Lu DOTA-SNA040 treatment; 6. Individuals known to have central nervous system metastases and/or malignant meningitis; 7. Major comorbidities: including but not limited to New York Heart Association grade III or IV congestive heart failure, a history of congenital QT interval prolongation syndrome, active severe infections, or other major diseases that the researcher deems unsuitable for participation in the study; 8. Patients with obvious gastric bleeding and/or untreated gastric ulcers; 9. Diagnosed with other malignant tumors that may alter life expectancy or interfere with disease assessment; 10. Pregnant or lactating women; 11. The researcher believes that they are not suitable to participate in this clinical study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200000, China
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- New injectable drug tested for safety in Hard-to-Treat solid tumors
- New antibody drug conjugate tested against advanced cancers