Smart drug delivers chemo directly to pancreatic cancer cells

NCT ID NCT07707674

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This early-phase trial tests an experimental drug called XNW28012 in people with metastatic pancreatic cancer whose disease has worsened after at least one prior treatment. XNW28012 is an antibody-drug conjugate designed to seek out a protein called tissue factor on cancer cells and deliver a chemotherapy drug directly to them. The study aims to evaluate the drug's safety, tolerability, and how it moves through the body, while also looking for signs of tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an antibody-drug conjugate called XNW28012 that targets tissue factor and delivers a chemotherapy drug
What this could lead to
If successful, this could point toward a new treatment option for metastatic pancreatic cancer, a disease with few effective therapies.
What could go wrong
This is an early, small Phase 1 trial focused on safety and dosing, so it is too soon to know if XNW28012 will be effective or have manageable side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

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. subjects with histologically or cytologically confirmed metastatic PDAC, whose disease has progressed after at least 1 prior systemic therapy. 2. Age ≥ 18 years old at the time of consent. 3. Subjects must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. ECOG status of 2 can be allowed if it is a result of disease progression and warrantsdiscussion with the medical monitor. 4. Subjects must have adequate organ function within 7 days prior to the first study drug administration, as indicated by the following laboratory values; 5. Life expectancy of at least 12 weeks. 6. Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study drug. 7. Non-sterile subjects must be willing to use a highly effective contraception (e.g., IUD, pill, or condom) for the duration of the study and for 6 months after the last dose of study drug unless their partner is sterilized. 8. Subjects are able to provide written informed consent, understand and are willing to comply with the requirements of the study. \- Exclusion Criteria: 1. A history of severe infusion reactions to other monoclonal antibodies/antibody drug conjugates (ADCs), or allergic reactions to any components of XNW28012, or treatment with TF-directed therapy. 2. Any anti-tumor therapy within 21 days prior to the first dose, including but not limited to: small molecules, immunotherapy, chemotherapy, monoclonal antibodies, or any other experimental drugs. 3. Any active malignancy, with the exception of the specific types of cancersunder investigation in this study and any locally recurring cancer that has been treated curatively . 4. Have received a live vaccine within 4 weeks prior to the first dose of study drug. Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed; however, intranasal influenza vaccines will not be allowed if they are attenuated live vaccines. 5. Have received granulocyte colony stimulating factor (G-CSF) or granulocyte / macrophage colony stimulating factor support within 1 week before screening, or pegylated G-CSF within 2 weeks before screening. 6. Subjects with toxicities (as a result of prior anti-cancer therapy) that have not improved to CTCAE grade ≤ 1 or stabilized, except those AEs not considered as a likely safety risk (e.g., alopecia). 7. Any history of pneumonitis or interstitial lung disease (ILD). 8. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack) ≤ 3 months prior to screening is allowed if stable. 9. Any hematological risk factors. 10. Clinically significant cardiovascular/cerebrovascular conditions. 11. Subjects have known active CNS metastases and/or carcinomatous meningitis. 12. Active ocular surface disease at screening, or subjects with any prior episode of cicatricial conjunctivitis, or corneal nebula; subjects with glaucoma of CTCAE grade ≥ 2. 13. Any history of Toxic Epidermal Necrolysis (TEN) or Steven Johnson Syndrome. 14. Subjects who have undergone major surgery within 28 days prior to the first dose of study drug, except if the procedure is minimally invasive. 15. Subjects with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is higher than 500 IU/mL or subjects with positive hepatitis C virus (HCV) RNA. Inactive hepatitis B surface antigen (HbsAg) carriers, treated and stable hepatitis B (HBV DNA \< 500 IU/mL), and cured hepatitis C subjects may be enrolled. 16. A known history of HIV infection or acquired immunodeficiency syndrome (AIDS). 17. Subjects with severe chronic or active infections requiring antibacterial, antifungal or antiviral therapy. 18. Known immunodeficiency or any condition that requires systemic treatment with either corticosteroids (≥ 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days before the first dose of study drug. 19. Subjects who have received (or plan to receive during the study treatment period) strong/moderate CYP3A4 inhibitors or inducers, or strong/moderate CYP2D6 inhibitors within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug. 20. Have an ongoing significant, uncontrolled medical condition. 21. Subjects who are pregnant or breastfeeding or expecting to conceive within the projected duration of the study. 22. Underlying medical conditions or alcohol, drug abuse or dependence that, in Investigator's opinion, will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or adverse events, or insufficient compliance during the study according to Investigator's judgment.

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Oklahoma University Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • SCRI at Mary Crowley

    Dallas, Texas, 75230, United States

  • START - Midwest

    Grand Rapids, Michigan, 49546, United States

    Contact Email: •••••@•••••

  • START - New York Long Island

    Lake Success, New York, 10042, United States

    Contact Email: •••••@•••••

  • START - San Antonio

    San Antonio, Texas, 78229, United States

    Contact Email: •••••@•••••

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