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AZD9592

Phase 1

Advanced Solid Tumours | Small molecule | Oncology |AstraZeneca PLC|Last Updated: May 11, 2026

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 Enrollment403
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05647122First in Human Study of AZD9592 in Solid TumorsPHASE1 RECRUITING 403 — — Dec 21, 2022Aug 2, 2028May 11, 202651 United States, Australia +9
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events (AEs)
From time of Informed Consent to 30 days post last dose of AZD9592

Number of patients with adverse events by system organ class and preferred term

Incidence of Serious Adverse Events (SAEs)
From time of Informed Consent to 30 days post last dose of AZD9592

Number of patients with serious adverse events by system organ class and preferred term

Incidence of dose-limiting toxicities (DLT) as defined in the protocol
From time of first dose of AZD9592 to end of DLT period (approximately 21 days)

Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol

Incidence of baseline laboratory finding, ECG and vital signs changes
From time of Informed Consent to 30 days post last dose of AZD9592

measured by laboratory and vital sign variables over time including change from baseline

Proportion of patients with radiological response (ORR)
From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)

Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1 (for patients in the dose expansion cohorts, only)

Secondary Endpoints
Objective Response Rate (ORR)
From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Duration of Response (DoR)
From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Disease Control Rate (DCR) at 12 weeks
From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (for each patient this is expected to be measured at 12 weeks)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Module 1 AZD9592 MonotherapyEXPERIMENTALModule 1 has two parts: Part A aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AZD9592. Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 as monotherapy in select solid tumors
Module 2 AZD9592 Combination with OsimertinibEXPERIMENTALModule 2 has two parts: Part A aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AZD9592 in combination with Osimertinib. Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 in combination with Osimertinib in NSCLC EGFRm
Module 3 AZD9592 Combination 5-FU, Bevacizumab, LeucovorinEXPERIMENTALModule 3 has two parts: Part A aims to determine the safety, tolerability and/or recommended phase 2 dose (RP2D) of AZD9592 in combination with 5-FU, Bevacizumab, Leucovorin in Colorectal Cancer (CRC) Part B aims to determine the safety, tolerability and evaluate anti-tumor activity of AZD9592 in combination with 5-FU, Bevacizumab, Leucovorin in Colorectal Cancer (CRC)
Interventions
NameTypeDescription
AZD9592DRUGVarying doses of AZD9592
OsimertinibDRUGtablets administered orally
5-Fluorouracil (5-FU)DRUGIV infusion
LeucovorinDRUGIV infusion
BevacizumabDRUGIV infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites51

Key Inclusion Criteria: * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1 * Life expectancy ≥ 12 weeks * Measurable disease per RECIST v1.1 * Adequate organ and marrow function as defined in the protocol Additional Inclusion Criteria for Module 1: • Histological...

Countries:United StatesAustraliaCanadaChinaFranceItalyJapanMalaysiaSouth KoreaSpainTaiwan
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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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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05647122primaryCompletionDate: changed
LOWMay 24, 2026NCT05647122studyFirstPostDate: changed