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MEDI7247

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Feb 28, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment67

FDA Designations

No designations recorded

Clinical trial landscape

MEDI7247 · 2 trials · 9 indications

Phase 1 2
NCT03811652A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid TumorsNon Small Cell Lung Cancer Squamous (NSCLC-Sq)
COMPLETED8 Analytics
NCT03106428A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological MalignanciesAcute Myeloid Leukemia
COMPLETED67 Analytics
PHASE1COMPLETED
A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors
Non Small Cell Lung Cancer Squamous (NSCLC-Sq)Unlock trial analytics
PHASE1COMPLETED
A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of Adverse Events
From time of informed consent through 90 days post end of treatment

To assess the occurrence of adverse events

Occurrence of Serious Adverse Events
From time of informed consent through 90 days post end of treatment

To assess the occurrence of serious adverse events

Occurrence of Dose Limiting Toxicities
During the evaluation period of 21 days post first dose

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

Number of patients with changes in laboratory parameters from baseline
From time of informed consent through 90 days post end of treatment

To assess serum chemistry, hematology, urinalysis and coagulation parameters

Number of patients with changes in vital signs parameters from baseline
from time of informed consent through 21 days post last dose

to assess changes in vital signs

Number of patients with changes in electrocardiogram results from baseline
from time of informed consent through 21 days post last dose

to assess changes in ECG

Percentage of patients with changes in laboratory parameters from baseline
from time of informed consent through 90 days post end of treatment

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

Occurrence of adverse events (AEs)
From time of informed consent through 90 days post end of treatment

To assess by the occurrence of adverse events (AEs)

Occurrence of serious adverse events (SAEs)
From time of informed consent through 90 days post end of treatment

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

Occurrence of dose-limiting toxicities (DLTs)
During the evaluation period of 21 or 42 days post-first dose

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

Number of patients with changes in vital signs from baseline
From time of informed consent and up to 21 days post end of treatment

To assess body temperature, blood pressure, and heart rate

Number of patients with changes in electrocardiogram (ECG) results from baseline
From time of informed consent and up to 21 days post end of treatment

To assess using twelve-lead ECG recordings

Secondary Endpoints

MEDI7247 maximum observed concentration (Cmax)
From first dose through 90 days post end of treatment
MEDI7247 terminal half life (t1/2)
From first dose through 90 days post end of treatment
MEDI7247 area under the concentration/time curve (AUC)
from first dose through 90 days post end of treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NSCLC-Sq/HNSCCEXPERIMENTALPatients 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.
Small Cell Lung CancerEXPERIMENTALPatients with advanced SCLC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen.
Colorectal CancerEXPERIMENTALPatients 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.
Pancreatic Ductal AdenocarcinomaEXPERIMENTALPatients 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.
Metastatic Castration-Resistant Prostate CancerEXPERIMENTALPatients with mCRPC who have received prior treatment with abiraterone or enzalutamide, with or without a prior taxane-based chemotherapy in the mCRPC setting.
Other advanced/metastatic target expressing solid tumorsEXPERIMENTALPatients 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
acute myeloid leukemiaEXPERIMENTALPatients 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
Multiple MyelomaEXPERIMENTALPatients 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.
Diffuse Large B-cell LymphomaEXPERIMENTALPatients with R/R DLBCL who have failed prior standard therapy(ies) and for whom there is no standard salvage regimen.

Interventions

NameTypeDescription
MEDI7247DRUGSubjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule
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Eligibility Criteria

Age Range18 Years to 101 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Confirmed diagnosis of advanced or metastatic select solid tumors and either progression on or documented intolerance to standard therapies 2. Age ≥ 18 years at the time of screening. 3. Written informed consent and any locally required authorization 4. Eastern Cooperative On...

Countries:United StatesCanadaFranceSouth Korea
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Frequently asked questions about MEDI7247

What is MEDI7247 used for?

MEDI7247 is an investigational small molecule being studied for the treatment of Non Small Cell Lung Cancer Squamous (NSCLC-Sq) and Acute Myeloid Leukemia. It has also been evaluated in other hematological malignancies and solid tumors, including multiple myeloma and head and neck squamous cell carcinoma.

Who makes MEDI7247?

MEDI7247 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The drug is currently in Phase 1 clinical development.

What phase is MEDI7247 in?

MEDI7247 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in patients with relapsed or refractory hematological malignancies and another in advanced or metastatic solid tumors. It is not yet approved and remains investigational.

What clinical trials is MEDI7247 in?

MEDI7247 has been studied in two completed Phase 1 trials. NCT03106428 enrolled 67 patients with Acute Myeloid Leukemia, Multiple Myeloma, and Diffuse Large B-cell Lymphoma. NCT03811652 enrolled 8 patients with solid tumors including NSCLC-Sq, HNSCC, SCLC, PDAC, CRC, and mCRPC.

Is MEDI7247 the same as any other drug?

MEDI7247 is the investigational name for this drug candidate. No alternative names have been disclosed in the available clinical trial information. It is distinct from other AstraZeneca oncology assets and is identified solely by the MEDI7247 designation.