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MEDI5083 monotherapy

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Jul 27, 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 Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03089645MEDI5083 Alone and in Combination With Durvalumab, Tremelimumab, and/or Docetaxel.PHASE1 COMPLETED 39 — — Mar 21, 2017Jun 23, 2020Jul 27, 20208 United States, Australia
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Study Endpoints
Primary Endpoints
Number of participants with Adverse Events (AEs) as a measure of safety
From the time of consent through 120 days after last treatment

Safety Endpoint

Number of participants with Serious Adverse Events (SAEs) as a measure of safety
From the time of consent through 120 days after last treatment

Safety Endpoint

Number of participants with Dose Limiting Toxicities (DLTs) as a measure of safety
From the time of first dose through 28 days thereafter

Safety Endpoint

The Maximum Tolerated Dose (MTD) or Highest Protocol-Defined Dose
From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)

Safety Endpoint

Discontinuation of investigational products due to toxicity
From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)

Safety Endpoint

Clinically significant alterations in vital signs, laboratory parameters, physical examination, and electrocardiogram (ECG) results.
From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)

Safety Endpoint

Antitumor activity endpoints OR, based on RECIST v1.1
Part 3

Safety Endpoint

Secondary Endpoints
Serum MEDI5083 concentration levels
From the time of first dose through 57 days after first treatment
Reduction in peripheral blood CD19+ B cells
From the time of first dose through 57 days after first treatment
Incidence of anti-drug antibody (ADA) responses to MEDI5083
From the time of first dose through 2 years after last treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1EXPERIMENTALMEDI5083 monotherapy followed by Durvalumab monotherapy in subjects with advanced solid tumors
Part 2EXPERIMENTALSequential MEDI5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab in subjects with advanced solid tumors.
Part 3EXPERIMENTALMedi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel in subjects with IO refractory/relapsed 2/3L in NSCLC
Interventions
NameTypeDescription
MEDI5083 monotherapyBIOLOGICALDose-escalation MEDI5083 monotherapy followed by monotherapy with Durvalumab
MEID5083 with Durvalumab or TremelimumabBIOLOGICALSequential Medi5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab
Medi5083 with Durvalumab and DocetaxelBIOLOGICALMedi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel
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Eligibility Criteria
Age Range18 Years — 101 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Age ≥ 18 years at the time of screening or age of consent according to local law 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 3. Histologically or cytologically confirmed metastatic or recurrent tumor types 4. Subjects who have received prior immu...

Countries:United StatesAustralia
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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