Can a smart drug outsmart pancreatic cancer?

NCT ID NCT07803783

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This phase III trial tests an experimental drug called YL201 against standard chemotherapy in people with metastatic pancreatic cancer that has progressed after gemcitabine-based treatment. YL201 is designed to deliver a toxin directly to cancer cells that carry a specific marker, B7-H3. The study compares how long the cancer stays under control and how long participants live with YL201 versus the usual care. Around 320 adults will take part, receiving either YL201 every three weeks or standard chemotherapy every two weeks.

What this could mean

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

Active substance
Tambotatug pelitecan (also called YL201), an experimental antibody-drug conjugate given by intravenous infusion every 3 weeks
What this could lead to
If YL201 works, it could offer a new treatment option for people with metastatic pancreatic cancer who have already tried gemcitabine-based chemotherapy, potentially slowing tumor growth and extending life.
What could go wrong
This is an early-stage test in a tough-to-treat cancer, so YL201 may not prove better than standard care. Side effects from the drug could also be serious, and results from this trial will need confirmation before the treatment becomes available.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 320 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

May 2029

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 to 75 years

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. Participants must voluntarily sign a written informed consent form (ICF) and be willing and able to comply with protocol requirements. 2. Participants must be ≥18 and ≤75 years of age. 3. Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 4. Participants must have a life expectancy of at least 3 months. 5. Participants must have histologically or cytologically confirmed incurable metastatic pancreatic ductal adenocarcinoma (PDAC). 6. Participants must have received and failed only one prior line of gemcitabine-based systemic therapy. 7. Participants must have at least one measurable lesion according to RECIST v1.1. 8. Participants must have adequate organ function as defined in the protocol. 9. Participants must agree to follow the contraception requirements specified in the protocol. Exclusion Criteria: 1. Participants with another malignancy within 5 years before randomization. 2. Participants with pathologically confirmed pancreatic cancer other than PDAC. 3. Participants who have previously received B7-H3-targeted therapy. 4. Participants who have previously received topoisomerase I inhibitor or antibody-drug conjugate containing topoisomerase I inhibitor. 5. Participants who are concurrently enrolled in another clinical study, unless it is an observational, non-interventional study or the participant is in the follow-up period of an interventional study. 6. Participants who have not met the protocol-specified washout requirements for prior systemic therapy, relevant concomitant medications, radiotherapy, or surgery before randomization, or who have not adequately recovered from prior surgery or are planning to undergo major surgery during the study. 7. Participants with protocol-specified exclusionary conditions related to central nervous system (CNS) metastases, history of transplantation, immunosuppressive therapy, live vaccine administration, or autoimmune or inflammatory diseases. 8. Participants with uncontrolled or clinically significant concomitant diseases, including serious gastrointestinal, cardiovascular or cerebrovascular, pulmonary, thromboembolic, bleeding-related, effusion-related, or ascites-related safety risks. 9. Participants with recent serious infection, active infection, active tuberculosis or syphilis, HIV positivity or immunodeficiency, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 10. Participants with unresolved toxicity from prior anticancer therapy that has not recovered to the level specified in the protocol. 11. Participants with known hypersensitivity to any component of the study treatment, or a history of severe hypersensitivity reactions or severe infusion-related reactions. 12. Participants who are pregnant or breastfeeding, planning to become pregnant or breastfeed, or who have any other medical, psychiatric, social, or compliance-related factors that, in the investigator's opinion, would make them unsuitable for participation in the 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.

  1. The study's own enquiry address

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

  2. The places running it

    1 site. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200127, China

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