Home › Trials › NCT06795022

Evaluating AZD9793 for advanced liver cancer

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)

Phase1; Phase2 Interventional AstraZeneca · NCT06795022

This study is testing a new treatment called AZD9793 to see if it can help people with advanced liver cancer that has a specific marker called GPC3.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment304 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsCAR-T, chimeric antigen receptor, radiation, prednisone
Locations20 sites (La Jolla, California and 19 other locations)
Trial IDNCT06795022 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, and anti-cancer activity of AZD9793, a T cell-engaging antibody targeting GPC3, in patients with advanced or metastatic solid tumors that are GPC3 positive. It is a first-in-human, open-label, multicenter trial consisting of two modules: one administering AZD9793 intravenously and the other subcutaneously. Each module includes a dose-escalation phase followed by a dose-expansion phase to further evaluate the treatment's effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with GPC3 positive hepatocellular carcinoma who have measurable lesions and meet specific health criteria.

Not a fit: Patients with non-GPC3 positive tumors or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced liver cancer.

How similar studies have performed: Other studies targeting GPC3 have shown promise, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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:

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.

Key Exclusion Criteria:

* 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.

Where this trial is running

La Jolla, California and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepatocellular CarcinomaGlypican-3GPC3GPC3+ tumoursT cell-engaging antibodyTCEAZD9793Solid tumours
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.