Hepatocellular CarcinomaPhase 1/2RHEA-1NCT06795022
First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours
A Phase 1/2 study testing AZD9793 Intravenous (IV) monotherapy and AZD9793 Subcutaneous (SC) monotherapy in people with Hepatocellular Carcinoma, run by AstraZeneca at 21 sites in 7 countries.
Trial summary
This research is designed to determine if experimental treatment with AZD9793, a T cell-engaging antibody that targets GPC3, is safe, tolerable and has anti-cancer activity in patients with advanced or metastatic solid tumours which are GPC3+. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- AZD9793 Intravenous (IV) monotherapy and AZD9793 Subcutaneous (SC) monotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 21 sitesin 7 countries
- Study dates
- 27 Mar 2025to 30 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 tissue collected after completion of the prior GPC3-targeted therapy.
- Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening.
- Predicted life expectancy of ≥ 12 weeks.
- Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol.
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- Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol.
- Confirmed advanced recurrent and/or metastatic and/or unresectable HCC, which is histopathologically proven based on the criteria established by the World Health Organization.
- Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
- Child-Pugh Score class A.
- Previous therapy:
- Part A: Patients who have received at least one prior line of standard systemic therapy for HCC as per National Comprehensive Cancer Network or other local scientific guidelines and for which a clinical study is the best option for next treatment based on prior response and/or tolerability and/or patient/investigator decision.
- Part B: Patients must not have received more than one prior line of systemic therapy in the advanced recurrent and/or metastatic setting.
Who cannot join
- Unresolved toxicity from prior anticancer therapy, including imAEs, of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for vitiligo, peripheral neuropathy related to prior anti-cancer therapy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities.
- Prior to enrolment, participation in another clinical study with an investigational product administered in the last 21 days or 5 half-lives whichever is shorter.
- CAR-T cell therapy within the last 6 months prior to enrolment on this study.
- Known allergy or hypersensitivity to AZD9793 or any of the excipients of the product as outlined in the IB.
- Requires chronic immunosuppressive therapy (including steroids > 10 mg prednisone/day or equivalent).
- Received radiation within 14 days prior to first dose of study treatment; palliative radiation to reduce the risk of tumour lysis syndrome (TLS) or CRS/neurotoxicity in participants with bulky disease is permitted.
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- Undergone a major surgical procedure within 14 days prior to first dose of study treatment days to allow adequate healing
- Experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy.
- Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS).
- Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment.
- Cardiac conditions as defined by the protocol.
- History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention.
- Central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent.
- Infectious disease including active human immunodeficiency virus (HIV), and uncontrolled active systemic fungal, bacterial or other infection.
- Known fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular malignant cholangiocarcinoma.
Trial locations and contacts
21 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
21 sites in 7 countries
United States7 sites, 6 recruiting
- Not yet recruiting
Research Site
Baltimore, Maryland, 21201
- Not yet recruiting
Research Site
Boston, Massachusetts, 02114
- Recruiting
Research Site
Hackensack, New Jersey, 07601
- Recruiting
Research Site
Houston, Texas, 77030
- Withdrawn
Research Site
La Jolla, California, 92093
- Recruiting
Research Site
Los Angeles, California, 90089
- Recruiting
Research Site
St Louis, Missouri, 63108
China4 sites, 4 recruiting
- Recruiting
Research Site
Chengdu, 610041
- Recruiting
Research Site
Guangzhou, 510515
- Not yet recruiting
Research Site
Harbin, 150049
- Recruiting
Research Site
Shanghai, 201114
Hong Kong2 sites, 2 recruiting
- Recruiting
Research Site
Pokfulam, 999077
- Recruiting
Research Site
Shatin, 000000
Japan2 sites, 2 recruiting
- Recruiting
Research Site
Kashiwa, 277-8577
- Recruiting
Research Site
Yokohama, 241-8515
South Korea2 sites, 2 recruiting
- Not yet recruiting
Research Site
Seoul, 06351
- Recruiting
Research Site
Seoul, 5505
Spain2 sites, 2 recruiting
- Not yet recruiting
Research Site
Barcelona, 8035
- Not yet recruiting
Research Site
Pamplona, 31005
Taiwan2 sites, 2 recruiting
- Recruiting
Research Site
Taipei, 10002
- Recruiting
Research Site
Taoyuan, 333
About this study
Official title: A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD9793, a T Cell-engaging Antibody Targeting Glypican-3 (GPC3) in Adult Participants With Advanced or Metastatic Solid Tumours (RHEA-1)
This research is designed to determine if experimental treatment with AZD9793, a T cell-engaging antibody that targets GPC3, is safe, tolerable and has anti-cancer activity in patients with advanced or metastatic solid tumours which are GPC3+.
Read the detailed description
This is a first-time in human, modular Phase I/II, open-label multicentre study of AZD9793 monotherapy administered intravenously (Module 1), or AZD9793 monotherapy administered subcutaneously (Module 2) in patients with advanced or metastatic solid tumours. Each module contains dose-escalation (Part A) and dose-expansion (Part B).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- AZD9793 Intravenous (IV) monotherapy, AZD9793 Subcutaneous (SC) monotherapy
- Keywords
- Glypican-3, GPC3, GPC3+ tumours, T cell-engaging antibody, TCE, AZD9793, Solid tumours, HCC
- Medical subject headings
- Carcinoma, Hepatocellular, Simpson-Golabi-Behmel syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9793 Intravenous (IV) monotherapyDrug
T cell-engaging antibody that targets GPC3 on tumour cells
AZD9793 Subcutaneous (SC) monotherapyDrug
T cell-engaging antibody that targets GPC3 on tumour cells
| Study group | Role | What they receive |
|---|---|---|
| Module 1: AZD9793 Intravenous (IV) monotherapy Part A | Experimental | Module 1: AZD9793 Intravenous (IV) monotherapy Part A: Dose Escalation Receives: Drug: AZD9793 Intravenous (IV) monotherapy |
| Module 2: AZD9793 Subcutaneous (SC) monotherapy Part A | Experimental | Module 2: AZD9793 Subcutaneous (SC) monotherapy Part A: Dose Escalation Receives: Drug: AZD9793 Subcutaneous (SC) monotherapy |
| Module 1: AZD9793 Intravenous (IV) monotherapy Part B | Experimental | Module 1: AZD9793 Intravenous (IV) monotherapy Part B: Dose Expansion Receives: Drug: AZD9793 Intravenous (IV) monotherapy |
| Module 2: AZD9793 Subcutaneous (SC) monotherapy Part B | Experimental | Module 2: AZD9793 Subcutaneous (SC) monotherapy Part B: Dose Expansion Receives: Drug: AZD9793 Subcutaneous (SC) monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with adverse events
Number of patients with adverse events by system organ class and preferred term
Measured: From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy
The number of patients with serious adverse events
Number of patients with serious adverse events by system organ class and preferred term
Measured: From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy
The number of patients with adverse events of special interest
Number of patients with adverse events of special interest by system organ class and preferred term
Measured: From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy
The number of AEs leading to discontinuation of AZD9793
Number of AEs that in the opinion of the Investigator or the Sponsor contraindicate further dosing or AEs that meet criteria for discontinuation
Measured: From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy
The number of patients with dose-limiting toxicity (DLT), as defined in the protocol [Part A Dose Escalation only]
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.
Measured: 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)
Objective Response Rate (ORR) [Part B Dose Expansion only]
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.
Measured: 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)
Secondary outcomes (15)
Objective Response Rate (ORR) [Part A Dose Escalation only]
The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1). Dose escalation only.
Measured: 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)
The best overall radiological visit response the participant achieves per RECIST 1.1 as assessed by the investigator.
Measured: 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)
The time from the date of first response until date of disease progression or death in the absence of disease progression, according to response criteria in solid tumours (RECIST 1.1).
Measured: From the first documented objective response (subsequently confirmed) to progressive disease or death in absence of progression (up to approximately 2 years)
Disease Control Rate (DCR) at 12 weeks
Percentage of patients with confirmed complete or partial response or having stable disease maintained for >= 11 weeks, at 12 weeks from first dose, according to response criteria in solid tumours (RECIST 1.1).
Measured: From first dose of study drug to progressive disease or last evaluable assessment in the absence of disease progression. [Expected to be measured for each patient at 12 weeks]
Durable response rate (DRR)
Percentage of participants who have a confirmed best overall response of CR or PR with a duration of at least 3 months, 6 months, 9 months, and 12 months.
Measured: From first documented objective response (subsequently confirmed) to the date of disease progression or the last evaluable assessment in the absence of progression (up to approximately 2 years)
Time To Response (TTR)
The time from start of study treatment until the date of first documented objective response, which is subsequently confirmed as assessed by the Investigator per RECIST 1.1.
Measured: From start of study treatment until the date of first documented objective response, which is subsequently confirmed as assessed by the Investigator per RECIST 1.1 (up to approximately 2 years)
Percentage change in tumour size
Percentage change from baseline in target lesion tumour size (sum of longest diameters of target lesions) based on the RECIST v1.1 target lesion measurements as assessed by the Investigator.
Measured: From first dose of study drug to the last evaluable assessment
Progression free Survival (PFS)
The time from the start of study treatment until RECIST 1.1 defined disease progression or death in the absence of disease progression.
Measured: From the start of study treatment to progressive disease or death due to any cause (up to approximately 2 years)
Overall Survival (OS) [Dose expansion only]
The time from the start of study treatment until death due to any cause. Dose expansion only.
Measured: From the start of study treatment to death (up to approximately 2 years)
Pharmacokinetics of AZD9793: Maximum serum concentration of the study drug (Cmax)
Maximum observed serum concentration of the study drug
Measured: From the first dose of study intervention, at predefined intervals throughout the study (up to approximately 2 years)
Pharmacokinetics of AZD9793: Area Under the concentration-time curve (AUC)
Area under the serum concentration-time curve
Measured: From the first dose of study intervention, at predefined intervals throughout the study (up to approximately 2 years)
Pharmacokinetics of AZD9793: Clearance
A pharmacokinetic measurement of the volume of serum from which the study drug is completely removed per unit time.
Measured: From the first dose of study intervention, at predefined intervals throughout the study (up to approximately 2 years)
Pharmacokinetics of AZD9793: Terminal elimination half-life (t 1/2)
Terminal elimination half life.
Measured: From the first dose of study intervention, at predefined intervals throughout the study (up to approximately 2 years)
Immunogenicity of AZD9793
The number and percentage of participants who develop anti-drug antibodies (ADAs) measured in serum
Measured: From the first dose of study intervention, at predefined intervals throughout the study (up to approximately 2 years)
Change in CD8+ Levels
Percentage change in CD8+ cells measured by IHC in samples taken pre and post treatment
Measured: From time of Informed consent, at predefined intervals (including screening, on-treatment or end of treatment) throughout the study (up to approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start27 Mar 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study consists of individual modules each evaluating the safety and tolerability of AZD9793 dosed as monotherapy: Module 1: AZD9793 intravenous administration Module 2: AZD9793 subcutaneous administration Modules 1 and 2 each consist of two parts: Part A, Dose Escalation and Part B, Dose Expansion.
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795022
- Sponsor's protocol ID
- D7040C00001
- Acronym
- RHEA-1
- Status last verified
- Oct 2026
- First submitted
- 8 Jan 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD9793, a T Cell-engaging Antibody Targeting Glypican-3 (GPC3) in Adult Participants With Advanced or Metastatic Solid Tumours (RHEA-1)
- ClinicalTrials.gov ID
- NCT06795022
- Acronym / sponsor ID
- RHEA-1 / D7040C00001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Glypican-3, GPC3, GPC3+ tumours, T cell-engaging antibody, TCE, AZD9793, Solid tumours, HCC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is designed to determine if experimental treatment with AZD9793, a T cell-engaging antibody that targets GPC3, is safe, tolerable and has anti-cancer activity in patients with advanced or metastatic solid tumours which are GPC3+.
Detailed description
This is a first-time in human, modular Phase I/II, open-label multicentre study of AZD9793 monotherapy administered intravenously (Module 1), or AZD9793 monotherapy administered subcutaneously (Module 2) in patients with advanced or metastatic solid tumours. Each module contains dose-escalation (Part A) and dose-expansion (Part B).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study consists of individual modules each evaluating the safety and tolerability of AZD9793 dosed as monotherapy: Module 1: AZD9793 intravenous administration Module 2: AZD9793 subcutaneous administration Modules 1 and 2 each consist of two parts: Part A, Dose Escalation and Part B, Dose Expansion.
| Arm | Type | Receives |
|---|---|---|
| Module 1: AZD9793 Intravenous (IV) monotherapy Part A | Experimental | Drug: AZD9793 Intravenous (IV) monotherapyModule 1: AZD9793 Intravenous (IV) monotherapy Part A: Dose Escalation |
| Module 2: AZD9793 Subcutaneous (SC) monotherapy Part A | Experimental | Drug: AZD9793 Subcutaneous (SC) monotherapyModule 2: AZD9793 Subcutaneous (SC) monotherapy Part A: Dose Escalation |
| Module 1: AZD9793 Intravenous (IV) monotherapy Part B | Experimental | Drug: AZD9793 Intravenous (IV) monotherapyModule 1: AZD9793 Intravenous (IV) monotherapy Part B: Dose Expansion |
| Module 2: AZD9793 Subcutaneous (SC) monotherapy Part B | Experimental | Drug: AZD9793 Subcutaneous (SC) monotherapyModule 2: AZD9793 Subcutaneous (SC) monotherapy Part B: Dose Expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 tissue collected after completion of the prior GPC3-targeted therapy.
- Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening.
- Predicted life expectancy of ≥ 12 weeks.
Key exclusion criteria (15 listed)
- Unresolved toxicity from prior anticancer therapy, including imAEs, of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for vitiligo, peripheral neuropathy related to prior anti-cancer therapy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities.
- Prior to enrolment, participation in another clinical study with an investigational product administered in the last 21 days or 5 half-lives whichever is shorter.
- CAR-T cell therapy within the last 6 months prior to enrolment on this study.
- Known allergy or hypersensitivity to AZD9793 or any of the excipients of the product as outlined in the IB.
- Requires chronic immunosuppressive therapy (including steroids > 10 mg prednisone/day or equivalent).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD9793 Intravenous (IV) monotherapyT cell-engaging antibody that targets GPC3 on tumour cells | Drug | Module 1: AZD9793 Intravenous (IV) monotherapy Part A, Module 1: AZD9793 Intravenous (IV) monotherapy Part B |
| AZD9793 Subcutaneous (SC) monotherapyT cell-engaging antibody that targets GPC3 on tumour cells | Drug | Module 2: AZD9793 Subcutaneous (SC) monotherapy Part A, Module 2: AZD9793 Subcutaneous (SC) monotherapy Part B |
Primary outcome
The number of patients with adverse events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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]
Time frame: 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]
Time frame: 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.
15 secondary outcomes
Objective Response Rate (ORR) [Part A Dose Escalation only]
Time frame: 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)
Time frame: 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)
Time frame: From the first documented objective response (subsequently confirmed) to progressive disease or death in absence of progression (up to approximately 2 years)
Disease Control Rate (DCR) at 12 weeks
Time frame: From first dose of study drug to progressive disease or last evaluable assessment in the absence of disease progression. [Expected to be measured for each patient at 12 weeks]
Durable response rate (DRR)
Time frame: From first documented objective response (subsequently confirmed) to the date of disease progression or the last evaluable assessment in the absence of progression (up to approximately 2 years)
Time To Response (TTR)
Time frame: From start of study treatment until the date of first documented objective response, which is subsequently confirmed as assessed by the Investigator per RECIST 1.1 (up to approximately 2 years)
Percentage change in tumour size
Time frame: From first dose of study drug to the last evaluable assessment
Progression free Survival (PFS)
Time frame: From the start of study treatment to progressive disease or death due to any cause (up to approximately 2 years)
Overall Survival (OS) [Dose expansion only]
Time frame: From the start of study treatment to death (up to approximately 2 years)
Pharmacokinetics of AZD9793: Maximum serum concentration of the study drug (Cmax)
Time frame: From the first dose of study intervention, at predefined intervals throughout the study (up to approximately 2 years)
Pharmacokinetics of AZD9793: Area Under the concentration-time curve (AUC)
Time frame: From the first dose of study intervention, at predefined intervals throughout the study (up to approximately 2 years)
Pharmacokinetics of AZD9793: Clearance
Time frame: From the first dose of study intervention, at predefined intervals throughout the study (up to approximately 2 years)
Pharmacokinetics of AZD9793: Terminal elimination half-life (t 1/2)
Time frame: From the first dose of study intervention, at predefined intervals throughout the study (up to approximately 2 years)
Immunogenicity of AZD9793
Time frame: From the first dose of study intervention, at predefined intervals throughout the study (up to approximately 2 years)
Change in CD8+ Levels
Time frame: From time of Informed consent, at predefined intervals (including screening, on-treatment or end of treatment) throughout the study (up to approximately 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD9793 Intravenous (IV) monotherapy and AZD9793 Subcutaneous (SC) monotherapy in people with Hepatocellular Carcinoma, run by AstraZeneca at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, China, Hong Kong, Japan, South Korea and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with adverse events (time frame: From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.