Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Heart and Blood Diseases

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoma, Non-Hodgkin

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Acute Graft Versus Host Disease

All Drugs and Chemicals

Immunomodulating Agents

Proteasome Inhibitors

Patients with R/R AML by World Health Organization (WHO) classification (Arber et al, 2016) who have failed prior standard therapy and for whom no standard therapies are available

Patients with R/R MM who have failed prior standard therapy(ies) which should include immunomodulatory agents and proteasome inhibitors and for whom there is no standard salvage regimen.

Patients with R/R DLBCL who have failed prior standard therapy(ies) and for whom there is no standard salvage regimen.

The study will enroll patients with R/R AML/MM/DLBCL who will receive MEDI7247 IV

MEDI7247

To assess safety and tolerability, describe the dose-limiting toxicities, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected hematological malignancies who have relapsed after, or are refractory to prior standard therapy, and for whom there is no standard salvage regimen available.

A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies

A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies

To assess by the occurrence of adverse events (AEs)

To assess by the occurrence of serious adverse events (SAEs)

To assess by the occurrence of non-Hematologic and hematologic toxicities, AEs, and abnormal laboratory results.

To assess serum chemistry, hematology, Coagulation and urinalysis

To assess body temperature, blood pressure, and heart rate

To assess using twelve-lead ECG recordings

To assess the Pharmacokinetics of MEDI7247

To assess the anti-tumor activity of MEDI7247

MedImmune LLC

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Digestive System Diseases

Carcinoma

Small Cell Lung Carcinoma

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Neoplasm Metastasis

Lung Neoplasms

Colorectal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplasms, Glandular and Epithelial

Small Cell Lung Cancer

Antineoplastic Agents

Herbal and Botanical

Oxaliplatin

Tegafur

Fluorouracil

Irinotecan

Antibodies

Capecitabine

Raltitrexed

Immunoglobulins

Taxane

Cola

Patients with advanced or metastatic NSCLC-Sq or HNSCC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen (platinum-based for HNSCC). PDL-1 positive patients should have received previous PD-1 or PD-L1 inhibitor where available.

Patients with advanced SCLC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen.

Patients with metastatic adenocarcinoma of the colon or rectum who have received and have progressed, or have documented intolerance, on prior thymidylate synthase inhibitor (eg, 5-fluorouracil (5-FU), capecitabine, raltitrexed, tegafur-uracil (UFT), irinotecan, and oxaliplatin for metastatic disease. If patients progress within 6 months of their last dose of adjuvant therapy this should be considered as a line of therapy in the metastatic setting. Patients with known RAS wildtype tumors must have received and progressed, or have documented intolerance, on anti-EGFR antibody. Patients with microsatellite instability-high or deficient mismatch repair tumors, must have received and progressed, or have documented intolerance on a PD-1 inhibitor, or PD-1 inhibitor plus cytotoxic T-lymphocyte antigen-4 inhibitor treatment where available.

Patients with unresectable, locally advanced or metastatic PDAC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior line of treatment.

Patients with mCRPC who have received prior treatment with abiraterone or enzalutamide, with or without a prior taxane-based chemotherapy in the mCRPC setting.

Patients with advanced or metastatic solid tumors not defined by other treatment arms who have positive expression of the protein target and have exhausted all approved therapies

Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule

To assess safety and tolerability, describe the dose-limiting toxicities, assess the preliminary antitumor activity, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected advanced or metastatic solid tumor malignancies that have received at least 1 prior line of treatment.

A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors

A Phase 1/1b Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI7247 in Patients With Advanced or Metastatic Disease in Selected Solid Tumors

To assess the occurrence of adverse events

To assess the occurrence of serious adverse events

To assess the occurrence of toxicities and abnormal laboratory results that may limit further dose administration

To assess serum chemistry, hematology, urinalysis and coagulation parameters

to assess changes in serum chemistry, hematology, urinalysis, and coagulation parameters

To characterize MEDI7247 single agent Pharmacokinetics

To characterize single agent MEDI7247 pharmacokinetics

to characterize the single agent MEDI7247 pharmacokinetics

To assess the antitumor activity of MEDI7247

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies	NCT03106428	Acute Myeloid L... Multiple Myelom... Diffuse Large B...	MEDI7247	18 Years - 100 Years	MedImmune LLC
A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors	NCT03811652	Non Small Cell ... Head and Neck S... Small Cell Lung... Pancreatic Duct... Colorectal Canc... Metastatic Cast...	MEDI7247	18 Years - 101 Years	MedImmune LLC

Spots Global Cancer Trial Database for medi7247

Every month we try and update this database with for medi7247 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for medi7247

Every month we try and update this database with for medi7247 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for medi7247 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.