New radioactive therapy targets Hard-to-Treat colorectal cancer
NCT ID NCT07590856
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new drug called SNA028 in 20 people with advanced colorectal cancer that has a specific marker (GPA33). The drug uses a two-step process to deliver radiation directly to cancer cells. The main goals are to check if it is safe and how the body handles it.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 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 colorectal cancer diagnosed by histopathology or cytology and experiencing imaging progression/recurrence after standard treatment; 6. According to RECIST 1.1 definition, there must be at least one measurable lesion; 7. Toxicity caused by previous treatment must be restored to ≤ level 2 (CTCAE v6.0) or to a stable state evaluated by the researcher (excluding hair loss and pigmentation); 8. Having sufficient organ function, defined as follows: 1\) Bone marrow: * White blood cell count 3.0\~10.0 × 10\^9/L * Absolute neutrophil count 1.5\~7.0 × 10\^9/L * Platelets 75\~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 9. 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. Poor nutritional status and inability to tolerate the test subjects; 2. Individuals who have previously been allergic to SNA028 components or their analogues; 3. Patients who have received therapeutic drugs and radiation therapy labeled with 177Lu and other radioactive isotopes 4 weeks before SNA028 treatment; 4. Patients who have received other experimental anti-tumor drug treatments 4 weeks before SNA028 treatment; 5. Patients who received anti-GPA33 antibody treatment 4 weeks before SNA028 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. Diagnosed with other malignant tumors that may alter life expectancy or interfere with disease assessment; 9. Pregnant or lactating women; 10. 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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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to why some cancer treatments work better
- Burning the edges: a new way to stop colon polyps from coming back
- Missed Follow-Up colonoscopies: do they raise the risk of advanced growths?
- A 2.2 mm scope could spot cancerous tissue in minutes, not days
- The gatekeepers of tumors: scientists probe how blood vessels let immune cells in
- New Antibody-Drug conjugate put to the test against Hard-to-Treat cancers