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New hope for pancreatic cancer: experimental drug MRG004A enters final testing phase

NCT ID NCT07138846

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 3 trial tests whether the experimental drug MRG004A, combined with best supportive care, helps people with advanced pancreatic cancer live longer compared to a placebo. The study plans to enroll 231 adults whose cancer has not responded to standard treatments. Participants will receive either MRG004A or a placebo, and researchers will track overall survival and tumor response.

What this could mean

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

Active substance
MRG004A (an experimental drug)
What this could lead to
If it works, this could provide a new treatment option to extend survival for people with advanced pancreatic cancer who have not responded to standard therapies.
What could go wrong
This is a phase 3 trial, but it is not yet recruiting. The drug may not improve survival or could cause side effects. Results may not apply to all patients.
Why investors are watching

LePu Biopharma is running a phase III trial of MRG004A, an experimental drug, against placebo in patients with advanced pancreatic cancer. For a small company, this late-stage readout is a major test of whether its main drug works, and the result will likely shape the company's future direction.

If it works: If the trial shows MRG004A controls the disease better than placebo, LePu Biopharma could have a viable treatment for a hard-to-treat cancer. That positive result might lead to regulatory approval and a commercial product, which would be a large step for a company of this size.

If it fails: Most drugs tested in phase III trials fail, and a negative or delayed result could leave LePu Biopharma without a clear path forward. The company's value depends heavily on this single trial, so a miss would be a serious setback.

AI-written from the trial record. Speculative, and not investment advice.

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 231 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jun 2027

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: * Willing to sign the informed consent form and follow the requirements specified in the protocol. * Patients with histologically and cytologically confirmed locally advanced or metastatic pancreatic cancer, including adenocarcinoma, who have failed at least prior systemic therapies including gemcitabine and fluorouracil. * Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). * The score of ECOG for performance status is 0 to 2. * Organ functions and coagulation function must meet the basic requirements. * Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment. Exclusion Criteria: * History of other primary malignant tumors * Active metastasis to brain or meninges * Active acute or chronic inflammatory skin disease, history of Steven-Johnson syndromes * History of active or chronic corneal and conjunctival diseases, or other clinically significant ocular diseases that affect the ophthalmic monitoring of the investigational drug * Received certain anti-tumor therapies or strong CYP3A4 inhibitors and have not complete the wash-out period, or have not fully recovered from major surgery * AEs due to prior anti-tumor therapy(ies) that have not resolved to ≤Grade 1 per CTCAE v5.0 * Presence of ≥Grade 2 peripheral neuropathy per CTCAE v5.0 * Poorly controlled pleural and peritoneal effusion or pericardial effusion * Severe cardiac dysfunction within 6 months before enrollment * History of ventricular tachycardia, or torsade des pointes * Uncontrolled or poorly controlled hypertension * Compression fractures of the spine that have not been treated with surgery and/or radiation therapy, or have not been stable within 2 weeks before randomization * Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug. * Patients with high risk of bleeding per investigator's judgement. * Patients who have active infection including but not limited to hepatitis B, hepatitis C, AIDS, or syphilis. * Active uncontrolled bacterial, viral, fungal, rickettsial, or parasitic infection. * Moderate to severe dyspnea at rest, severe primary lung disease, interstitial lung disease, or pneumonia. * Uncontrolled pain due to cancer * Active or history of autoimmune disease that requiring systemic hormone therapy * History of hypersensitivity to any component of the investigational product. * Other situations that are not suitable to participate a clinical trial per investigator's judgement

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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

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

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