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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment33
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02991911A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate CancerPHASE1 COMPLETED 33 — — Jan 6, 2017Sep 30, 2019Jan 18, 20205 United States, Switzerland +1
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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 — 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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