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AZD0156

Phase 1

Advanced Solid Tumours | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Sep 19, 2022

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment84
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02588105Study to Assess the Safety and Preliminary Efficacy of AZD0156 at Increasing Doses Alone or in Combination With Other Anti-cancer Treatment in Patients With Advanced CancerPHASE1 COMPLETED 84 — — Nov 10, 2015Jul 26, 2022Sep 19, 20225 United States, South Korea +2
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Study Endpoints
Primary Endpoints
Safety and tolerability - Number of patients experiencing adverse events
Informed consent until end of Safety Follow-up (approximately 6 months)

Safety and tolerability of AZD0156 alone or in combination with either olaparib, cytotoxic chemotherapies, or novel anti-cancer agents as assessed through collection of Adverse Event, Serious Adverse Event, Clinical Chemistry/Haematology/Coagulation/Vital Signs and ECG

Secondary Endpoints
Anti-tumour activity assessed through tumour measurements
Baseline and then every 6 weeks until Safety follow-up (approximately 6 months)
Changes in expression levels of proteins that may be impacted by ATM protein activity or inhibition
From baseline until 21 days of combination therapy (Approximately 11 assessments)
Changes in the number of CTCs (Circulating Tumour Cells)
From baseline until 21 days of combination therapy (Approx 6 assessments)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Safety and TolerabilityEXPERIMENTALAll patients will receive AZD0156 as a monotherapy or in combination with either olaparib, cytotoxic chemotherapies, or novel anti-cancer agents to assess safety and tolerability
Interventions
NameTypeDescription
AZD0156DRUGAll patients will receive AZD0156 as a monotherapy or in combination to assess safety and tolerability.
OlaparibDRUGModule 1 combination with olaparib
irinotecanDRUGModule 2 combination with irinotecan/FOLFIRI
FluorouracilDRUGModule 2 combination with irinotecan/FOLFIRI
Folinic AcidDRUGModule 2 combination with irinotecan/FOLFIRI
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Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion criteria for all parts of the study * Confirmation of locally advanced/metastatic cancer. Refractory or resistant to standard therapy, or have no effective standard * Aged at least 18 yrs * Reasonable health (performance status 0 or 1), stable over the previous 2 weeks * Females who can h...

Countries:United StatesSouth KoreaSpainUnited Kingdom
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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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