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Study of AZD9793 for Advanced or Metastatic Solid Tumours

This study is testing a new treatment called AZD9793 for people with advanced or metastatic solid tumours that are GPC3 positive. AZD9793 is a T cell-engaging antibody, which means it helps your body's immune cells (T cells) find and fight cancer cells. Researchers want to see if AZD9793 is safe, how well people tolerate it, and if it can help shrink tumours. The treatment will be given either into a vein (intravenous or IV) or under the skin (subcutaneous or SC). The main goal is to track any side effects you might experience. You may be able to join if you are 18 or older and your tumour has a specific marker called GPC3.

Study design
This is a first-time in human, open-label study with an estimated 304 participants. It has two parts: a dose-escalation phase to find the right dose, and a dose-expansion phase to further evaluate the treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track side effects from your first dose up to 30 days after your last dose, or until you start another cancer treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06795022

First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours

Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~304 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:AZD9793 Intravenous (IV) monotherapyAZD9793 Subcutaneous (SC) monotherapy

At a glance

Recruiting sites
13 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of patients with adverse events
Measured over From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy
+5 more outcomes measured

Conditions

Hepatocellular Carcinoma

Explore related trials

Hepatocellular CarcinomaSolid NeoplasmGlypican-3

Where it's being run

21 sites across 12 states
China4
California2
Hong Kong2
Japan2
South Korea2
Spain2
Taiwan2
Maryland1

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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:

Exclusion

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.
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.

What this trial measures

  • The number of patients with adverse eventsFrom 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 eventsFrom 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 interestFrom 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 AZD9793From 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.