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Multi-arm phase 2 study of Magrolimab in patients with solid tumors

THIS STUDY IS DIVIDED INTO TWO PARTS. THE INITIAL PHASE (SAFETY PREINCLUSION) CONSISTS OF CONFIRMING A SAFE DOSE OF MAGROLIMAB IN COMBINATION WITH DOCETAXEL, AND THE SECOND PART (PHASE 2) CONSISTS OF SEEING IF MAGROLIMAB IN COMBINATION WITH DOCETAXEL IS EFFECTIVE IN THE TREATMENT OF VARIOUS TYPES OF SOLID TUMORS. OTHER OBJECTIVES OF THIS STUDY ARE TO DETERMINE THE AMOUNT OF MAGROLIMAB IN THE BLOOD, ITS QUALITY OF LIFE AND THE SIDE EFFECTS THAT THESE DRUGS HAVE ON THE BODY. THE MAIN OBJECTIVE OF THIS STUDY IS TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF MAGROLIMAB IN COMBINATION WITH DOCETAXEL IN METASTATIC NON-SMALL CELL LUNG CANCER (MNSCLC), METASTATIC UROTHELIAL CANCER (MUC) AND METASTATIC MICROCYTIC LUNG CANCER (MMLC). THE CURRENT STANDARD OF CARE FOR METASTATIC SOLID TUMORS INCLUDES A COMBINATION OF CHEMOTHERAPY AND IMMUNE CHECKPOINT INHIBITORS. PATIENTS WHO FAIL FIRST-LINE TREATMENT WITH CHEMOTHERAPY AND/OR IMMUNE CHECKPOINT INHIBITORS HAVE A POOR PROGNOSIS AND LIMITED TREATMENT OPTIONS. DOCETAXEL, CHEMOTHERAPY THAT DISRUPTS THE MICROTUBULAR NETWORK IN CELLS THAT PREVENTS CANCER CELLS FROM REPRODUCING AND DIVIDING, IS USED IN MNSCLC, UC AND MMPC FOR PATIENTS WHO FAIL FIRST-LINE THERAPY. THIS STUDY INVESTIGATES WHETHER THE COMBINATION OF A NEW DRUG MAGROLIMAB WITH DOCETAXEL IN PATIENTS WITH METASTATIC SOLID TUMORS IMPROVES CLINICAL ACTIVITY WITH AN ACCEPTABLE SAFETY PROFILE.

Status
In recruitment
headquarters
Pamplona

Technical Summary

  • MULTI-ARM PHASE 2 STUDY OF MAGROLIMAB IN PATIENTS WITH SOLID TUMORS. IMMUNOTHERAPY
  • Code EudraCT: 2020-005265-14
  • Protocol number: GS-US-548-5918
  • Promoter: Gilead Science
  • Link to Clinical Trials

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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