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MEDI3726 Post-Chemo

Phase 1

Metastatic Castration Resistant Prostate Cancer | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Jan 18, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

MEDI3726 Post-Chemo · 1 trial · 1 indication

Phase 1 1
NCT02991911A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate CancerMetastatic Castration Resistant Prostate Cancer
COMPLETED33 Analytics
PHASE1COMPLETED
A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer
Metastatic Castration Resistant Prostate Cancer
NCT0299191133
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Study Endpoints

Primary Endpoints

Occurrence of adverse events (AEs)
From time of informed consent through 90 days after last dose of MEDI3726

Safety Endpoint

Occurrence of serious adverse events (SAEs)
From time of informed consent through 90 days after last dose of MEDI3726

Safety Endpoint

Occurrence of dose-limiting toxicities (DLTs)
From time of first dose through 21 days after first dose of MEDI3726

Safety Endpoint

Number of patients with changes in laboratory parameters from baseline
From time of informed consent through 90 days after last dose of MEDI3726

Safety Endpoint

Number of patients with changes in vital signs from baseline
From time of informed consent through 21 days after last dose of MEDI3726

Safety Endpoint

Number of patients with changes in electrocardiogram (ECG) results from baseline
From time of informed consent through 21 days after last dose of MEDI3726

Safety Endpoint

Secondary Endpoints

Response Evaluation Criteria in Solid Tumors (RECIST) response
From time of informed consent through 90 days after last dose of MEDI3726
PSA50 response
From time of fist dose through at least 12 weeks after first dose of MEDI3726
Circulating Tumor Cell (CTC) response
From time of informed consent through 90 days after last dose of MEDI3726
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTALMEDI3726 Post-Chemo
Arm BEXPERIMENTALMEDI3726 Pre-Chemo
Arm CEXPERIMENTALMEDI3726 \& Enzalutamide Combo

Interventions

NameTypeDescription
MEDI3726 Post-ChemoBIOLOGICALSingle agent MEDI3726 after abiraterone or enzalutatmide, with a prior taxane-based chemotherapy in the mCRPC setting
MEDI3726 Pre-ChemoBIOLOGICALSingle agent MEDI3726 after abiraterone or enzalutatmide, without a prior taxane-based chemotherapy in the mCRPC setting
MEDI3726 & Enzalutamide ComboBIOLOGICALMEDI3726 in combination with Enzalutatmide after prior treatment with abiraterone, with or without a prior taxane-based chemotherapy in the mCRPC setting
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Eligibility Criteria

Age Range18 Years to 100 Years
SexMALE
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Age ≥ 18 years at the time of screening. * Histologically confirmed diagnosis of metastatic castration-resistant prostate adenocarcinoma (mCRPC). * Documented PD in subjects with mCRPC as assessed by the Investigator and defined by at least one of the following according to th...

Countries:United StatesSwitzerlandUnited Kingdom
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Frequently asked questions about MEDI3726 Post-Chemo

What is MEDI3726 Post-Chemo used for?

MEDI3726 Post-Chemo is an investigational monoclonal antibody being studied for the treatment of metastatic castration resistant prostate cancer. It is intended for adult male patients with this condition. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes MEDI3726 Post-Chemo?

MEDI3726 Post-Chemo is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug in patients with metastatic castration resistant prostate cancer.

What phase is MEDI3726 Post-Chemo in?

MEDI3726 Post-Chemo is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies for commercial use. The Phase 1 study has been completed, and the drug remains under evaluation for the treatment of metastatic castration resistant prostate cancer.

What clinical trials is MEDI3726 Post-Chemo in?

MEDI3726 Post-Chemo has been studied in a Phase 1/1b clinical trial with the identifier NCT02991911. This trial, titled 'A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer,' has been completed. The study enrolled 33 participants and was conducted in the United States, Switzerland, and the United Kingdom.

Is MEDI3726 Post-Chemo the same as MEDI3726?

MEDI3726 Post-Chemo is the same drug as MEDI3726, with the name indicating the patient population studied, specifically those who have previously received chemotherapy. The drug is an investigational monoclonal antibody being developed by AstraZeneca for metastatic castration resistant prostate cancer.