Advanced Pancreatic CancerPhase 3NCT07138846
A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer
A Phase 3 study of Advanced Pancreatic Cancer, run by Lepu Biopharma Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, multi-center, phase III study to evaluate the efficacy and safety, pharmacokinetic profile and immunogenicity of MRG004A in patients with advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Cancer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 1 siteChina
- Study dates
- Jan 2027to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xianjun Yu, M.D., 86-21-64175590, yuxianjun@fudanpci.org
About this study
Official title: A Randomized, Double-blind, Multi-center, Phase III Study of MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer
This is a randomized, double-blind, multi-center, phase III study to evaluate the efficacy and safety, pharmacokinetic profile and immunogenicity of MRG004A in patients with advanced pancreatic cancer.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- MRG004A plus best supportive care, Placebo plus best supportive care
- Keywords
- MRG004A, Best Supportive Care, Placebo Controlled, Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG004A plus best supportive careDrug
MRG004A will be administrated as specified in the protocol.
Placebo plus best supportive careDrug
Placebo will be administrated as specified in the protocol, following the same dose regimen as MRG004A.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Interventions administered to this arm include MRG004A, which is the investigational drug product, plus best supportive care, including but not limited to pain management, nutrition support, and psychological therapy Receives: Drug: MRG004A plus best supportive care |
| Control Arm | Placebo comparator | Placebo plus best supportive care, the definition of best supportive care is the same as that in the experiment arm Receives: Drug: Placebo plus best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the duration from the start of treatment to death of any cause.
Measured: Baseline to study completion (up to 24 months)
Secondary outcomes (7)
Progression Free Survival (PFS)
PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.
Measured: Baseline to study completion (up to 24 months)
Objective Response Rate (ORR)
ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.
Measured: Baseline to study completion (up to 24 months)
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.
Measured: Baseline to study completion (up to 24 months)
Duration of Response (DOR)
The time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier.
Measured: Baseline to study completion (up to 24 months)
Immunogenicity (ADA)
The proportion of patients with positive ADA results.
Measured: Baseline to 14 days after the last dose.
Adverse Events (AEs)
Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.
Measured: Baseline to 30 days after the last dose of study treatment
Serious Adverse Events (SAEs)
Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability/incapacity/substantial disruption of the ability to lead a normal life, congenital anomaly/birth defect or major medical events or reactions
Measured: Baseline to 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startJan 2027 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 231 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lepu Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xianjun Yu, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138846
- Sponsor's protocol ID
- MRG004A-002
- Status last verified
- May 2026
- First submitted
- 17 Aug 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Phase III Study of MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07138846
- Acronym / sponsor ID
- MRG004A-002
- Conditions
- Advanced Pancreatic Cancer
- Keywords
- MRG004A, Best Supportive Care, Placebo Controlled, Pancreatic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- Lepu Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, multi-center, phase III study to evaluate the efficacy and safety, pharmacokinetic profile and immunogenicity of MRG004A in patients with advanced pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: MRG004A plus best supportive careInterventions administered to this arm include MRG004A, which is the investigational drug product, plus best supportive care, including but not limited to pain management, nutrition support, and psychological therapy |
| Control Arm | Placebo comparator | Drug: Placebo plus best supportive carePlacebo plus best supportive care, the definition of best supportive care is the same as that in the experiment arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRG004A plus best supportive careMRG004A will be administrated as specified in the protocol. | Drug | Experimental Arm |
| Placebo plus best supportive carePlacebo will be administrated as specified in the protocol, following the same dose regimen as MRG004A. | Drug | Control Arm |
Primary outcome
Overall Survival (OS)
Time frame: Baseline to study completion (up to 24 months)
OS is defined as the duration from the start of treatment to death of any cause.
7 secondary outcomes
Progression Free Survival (PFS)
Time frame: Baseline to study completion (up to 24 months)
Objective Response Rate (ORR)
Time frame: Baseline to study completion (up to 24 months)
Disease Control Rate (DCR)
Time frame: Baseline to study completion (up to 24 months)
Duration of Response (DOR)
Time frame: Baseline to study completion (up to 24 months)
Immunogenicity (ADA)
Time frame: Baseline to 14 days after the last dose.
Adverse Events (AEs)
Time frame: Baseline to 30 days after the last dose of study treatment
Serious Adverse Events (SAEs)
Time frame: Baseline to 30 days after the last dose of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xianjun Yu, M.D. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Advanced Pancreatic Cancer, run by Lepu Biopharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Program Director (86-21-61637960, clinicaltrials@miracogen.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Baseline to study completion (up to 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.