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AZD9793 monotherapy

Phase 1

Hepatocellular Carcinoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Apr 6, 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 Enrollment304
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06795022First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid TumoursPHASE1 RECRUITING 304 — — Mar 27, 2025Jul 25, 2028Apr 6, 202620 United States, China +5
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Study Endpoints
Primary Endpoints
The number of patients with adverse events
From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy

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

The number of patients with serious adverse events
From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy

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

The number of patients with adverse events of special interest
From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy

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

The number of AEs leading to discontinuation of AZD9793
From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy

Number of AEs that in the opinion of the Investigator or the Sponsor contraindicate further dosing or AEs that meet criteria for discontinuation

The number of patients with dose-limiting toxicity (DLT), as defined in the protocol [Part A Dose Escalation only]
From date of first dose of study drug until the end of DLT evaluation period (up to 21, 28 or 35 days depending on dose regimen)

Number of patients with at least 1 DLT. A DLT is a toxicity as defined in the protocol that occurs from the first dose of study drug up to and including the planned end of the DLT evaluation period that is assessed as unrelated to the disease or disease-related processes under investigation.

Objective Response Rate (ORR) [Part B Dose Expansion only]
From first dose of study drug to progressive disease or the last evaluable assessment in the absence of disease progression whichever comes first (up to approximately 2 years)

The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1). Dose expansion only.

Secondary Endpoints
Objective Response Rate (ORR) [Part A Dose Escalation only]
From first dose of study drug to progressive disease or the last evaluable assessment in the absence of disease progression whichever comes first (up to approximately 2 years)
Best overall response (BOR)
From first dose until disease progression or the last evaluable assessment in the absence of progression (up to approximately 2 years)
Duration of response (DoR)
From the first documented objective response (subsequently confirmed) to progressive disease or death in absence of progression (up to approximately 2 years)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Module 1: AZD9793 Intravenous (IV) monotherapy Part AEXPERIMENTALModule 1: AZD9793 Intravenous (IV) monotherapy Part A: Dose Escalation
Module 2: AZD9793 Subcutaneous (SC) monotherapy Part AEXPERIMENTALModule 2: AZD9793 Subcutaneous (SC) monotherapy Part A: Dose Escalation
Module 1: AZD9793 Intravenous (IV) monotherapy Part BEXPERIMENTALModule 1: AZD9793 Intravenous (IV) monotherapy Part B: Dose Expansion
Module 2: AZD9793 Subcutaneous (SC) monotherapy Part BEXPERIMENTALModule 2: AZD9793 Subcutaneous (SC) monotherapy Part B: Dose Expansion
Interventions
NameTypeDescription
AZD9793 Intravenous (IV) monotherapyDRUGT cell-engaging antibody that targets GPC3 on tumour cells
AZD9793 Subcutaneous (SC) monotherapyDRUGT cell-engaging antibody that targets GPC3 on tumour cells
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites20

Key Inclusion Criteria: * Age ≥ 18 at the time of signing the informed consent. * GPC3 positive tumour as determined by a central laboratory using an analytically validated IHC assay. Patients who previously received any therapy targeting GPC3 must undergo central laboratory GPC3 testing on tumour ...

Countries:United StatesChinaHong KongJapanSouth KoreaSpainTaiwan
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06795022primaryCompletionDate: changed
LOWMay 24, 2026NCT06795022studyFirstPostDate: changed