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AZD9793 monotherapy

Phase 1

Hepatocellular Carcinoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 13, 2026

Target and mechanism

ModalitySmall molecule

Also known as AZD9793 Intravenous (IV) monotherapy

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment304

FDA Designations

No designations recorded

Clinical trial landscape

AZD9793 monotherapy · 1 trial · 1 indication

Phase 1 1
NCT06795022First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid TumoursHepatocellular Carcinoma
RECRUITING304 Analytics
PHASE1RECRUITING
First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours
Hepatocellular CarcinomaUnlock trial analytics

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 to N/A
SexALL
Healthy VolunteersNo
Study Sites21

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)

LOWAug 14, 2026NCT06795022primaryCompletionDate: changed
LOWAug 14, 2026NCT06795022primaryCompletionDate: changed
LOWAug 14, 2026NCT06795022primaryCompletionDate: changed

Frequently asked questions about AZD9793 monotherapy

What is AZD9793 used for?

AZD9793 is an investigational small molecule being studied for the treatment of hepatocellular carcinoma, a type of liver cancer. It is currently in Phase 1 clinical development as a monotherapy for patients with advanced or metastatic solid tumors, including hepatocellular carcinoma.

What does AZD9793 target?

The specific molecular target of AZD9793 has not been disclosed in available information. It is described as a small molecule therapeutic being evaluated in a first-in-human study for advanced or metastatic solid tumors, including hepatocellular carcinoma.

Who is developing AZD9793?

AZD9793 is being developed by AstraZeneca PLC, a global biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting a Phase 1 clinical trial to evaluate the drug as a monotherapy in patients with hepatocellular carcinoma.

What phase is AZD9793 in?

AZD9793 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is a first-in-human study designed to evaluate the safety, tolerability, and preliminary efficacy of AZD9793 in participants with advanced or metastatic solid tumors.

What clinical trials is AZD9793 in?

AZD9793 is being studied in a single Phase 1 clinical trial with the identifier NCT06795022. This first-in-human study is recruiting participants with hepatocellular carcinoma and is being conducted in the United States, China, Hong Kong, Japan, South Korea, Spain, and Taiwan. The trial aims to enroll 304 participants aged 18 years and older.

Is AZD9793 the same as AZD9793 Intravenous monotherapy?

Yes, AZD9793 is also known as AZD9793 Intravenous (IV) monotherapy. This alternative name reflects the route of administration and the fact that it is being studied as a single agent, without combination with other therapies, in the ongoing clinical trial.