Clinical trial · Interventional
A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer
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
NCT07138846CI-TRIAL-00111753not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRG004A plus best supportive care | Drug | — | UNRESOLVED |
| Placebo plus best supportive care | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- 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
- interventionNames
- Drug: MRG004A plus best supportive care
- type
- PLACEBO_COMPARATOR
- label
- Control Arm
- description
- Placebo plus best supportive care, the definition of best supportive care is the same as that in the experiment arm
- interventionNames
- Drug: Placebo plus best supportive care
Primary outcomes (1)
- measure
- Overall Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.