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New drug trial hopes to shrink Hard-to-Treat pancreatic tumors

NCT ID NCT07561463

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.