New drug trial hopes to shrink Hard-to-Treat pancreatic tumors
NCT ID NCT07561463
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests a drug called sacituzumab tirumotecan in 30 people with advanced pancreatic cancer that has worsened after at least one prior treatment. The drug is given by IV every two weeks. The main goal is to see if it can shrink tumors, and researchers will also track how long the effect lasts and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sacituzumab tirumotecan (a drug given by IV every 2 weeks)
- What this could lead to
- If it works, this could offer a new treatment option for people with advanced pancreatic cancer who have run out of standard therapies.
- What could go wrong
- This is a small, early-phase trial with only 30 people, so results may not apply to everyone. The drug may cause side effects or fail to shrink tumors.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 years and older
- 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. Voluntary participation with written informed consent provided 2. Age ≥18 years at the time of signing the informed consent form 3. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (including adenosquamous carcinoma) 4. Failure of or disease progression after at least one prior line of systemic therapy for locally advanced or metastatic pancreatic cancer 5. At least one measurable target lesion at baseline per RECIST 1.1 criteria (a single measurable lesion must not have received prior radiotherapy, or must have demonstrated clear progression after radiotherapy) 6. ECOG performance status score of 0-2 7. Adequate organ and bone marrow function (including hematologic, hepatic, renal, and coagulation parameters meeting specified criteria) 8. Subjects of childbearing potential must use highly effective contraception, and female subjects must have a negative pregnancy test 9. Ability and willingness to comply with study-related procedures. Exclusion Criteria: 1. History of or current presence of central nervous system metastases 2. Presence of untreated or unstable spinal cord compression 3. High risk of gastrointestinal or intra-abdominal bleeding 4. Prior treatment with TROP2-targeted agents or antibody-drug conjugates (ADCs) 5. Requirement for strong CYP3A4 inhibitors or inducers within 2 weeks prior to the first dose, or inability to avoid their use during the study 6. History of severe dry eye syndrome, meibomian gland disease, or other corneal disorders that may impair corneal healing 7. Major surgery within 28 days prior to the first dose (excluding palliative procedures), or receipt of curative radiotherapy within 3 months 8. Presence of other malignancies within 3 years prior to the first treatment (except for certain definitively treated cancers) 9. Uncontrolled severe systemic diseases such as cardiovascular or cerebrovascular disease, diabetes mellitus, or hypertension 10. History of interstitial lung disease or non-infectious pneumonitis, or current related lesions 11. Presence of severe underlying pulmonary disease, autoimmune disease, or prior total pneumonectomy 12. Active chronic inflammatory bowel disease, gastrointestinal obstruction, or other severe gastrointestinal disorders 13. Tumor invasion of critical organs or vessels with associated symptoms, or risk of fistula formation 14. Toxicities from prior antitumor therapy not recovered to ≤ Grade 1 (except for low-risk toxicities) 15. Active hepatitis B, hepatitis C, HIV infection, or active syphilis 16. Known allergy to the investigational drug or its components, or history of severe hypersensitivity to other biologic agents 17. Severe infection within 4 weeks prior to dosing, or active infection requiring systemic therapy within 2 weeks 18. Receipt of non-specific immunomodulatory therapy or antitumor traditional Chinese medicine within 2 weeks prior to dosing 19. Receipt of live vaccines within 30 days prior to dosing or planned during the study period 20. Pregnant or breastfeeding women, or individuals of childbearing potential who are not using highly effective contraception as required 21. Individuals considered vulnerable populations (e.g., patients with psychiatric disorders or critically ill patients), or any other condition deemed unsuitable for enrollment by the investigator.
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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 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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Triple attack on pancreatic tumors: can radiation and immunotherapy make inoperable cancer operable?
- Old antiparasitic drug joins chemo in pancreatic cancer fight
- Alpha radiation targets tumors in new cancer trial
- Can a pill duo outsmart a Hard-to-Treat pancreatic cancer mutation?
- AI takes aim at pancreatic cancer: can it forecast chemotherapy outcomes?
- Can a smart drug outsmart pancreatic cancer?