New hope for pancreatic cancer: experimental drug MRG004A enters final testing phase
NCT ID NCT07138846
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 231 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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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: * 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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Genom att skicka in godkänner du våra Användarvillkor
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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Personalized drug matching put to the test in pancreatic cancer
- Can engineered immune cells tackle Hard-to-Treat KRAS cancers?
- Can a new injection boost chemotherapy against pancreatic cancer?
- Can a targeted antibody slow advanced pancreatic cancer?
- New Antibody-Drug combo takes on Hard-to-Treat pancreatic cancer
- New drug targets Hard-to-Treat pancreatic cancer by hitting a common mutation