A trial to learn how safe AZD9793 is, how it moves throughout the body over time, how it affects the body, and how well it works in adults with advanced or metastatic solid tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-03-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AstraZeneca AB

External identifiers

EU CT number

2024-516698-56-00

ClinicalTrials.gov

NCT06795022

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Pharmacokinetic, Efficacy, Pharmacodynamic

To investigate the safety and tolerability, and determine the Maximum Tolerated Dose (MTD), Optimal Biological Dose (OBD), and/or Recommended Dose(s) for Expansion (RDEs), as well as the Recommended Phase 2 Dose(s) (RP2Ds), of AZD9793 monotherapy, and to evaluate its preliminary anti‑tumour activity in participants with advanced or metastatic solid tumours with GPC3 expression

Secondary objectives 1

1. To evaluate the preliminary anti-tumour activity and characterise the PK of AZD9793 monotherapy, as well as to determine the immunogenicity of AZD9793 monotherapy and to assess the TME pre- and post-administration of AZD9793 monotherapy

Conditions and MedDRA coding

Hepatocellular Carcinoma

Study design 5 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Age ≥ 18 at the time of signing the informed consent
2. 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
3. Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
4. Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening
5. Predicted life expectancy of ≥ 12 weeks.
6. Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol.
7. Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol.
8. Confirmed advanced recurrent and/or metastatic and/or unresectable HCC, which is histopathologically proven based on the criteria established by the World Health Organization.
9. Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
10. Child-Pugh Score class A.
11. Previous therapy: Part A: Patients who have received at least one prior line of standard systemic therapy for HCC as per NCCN 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.
12. Previous therapy: Part B: Patients must not have received more than 1 prior line of systemic therapy in the advanced recurrent and/or metastatic setting.

Exclusion criteria 15

1. Unresolved toxicity from prior anticancer therapy, including irAEs, 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.
2. Known allergy or hypersensitivity to AZD9793 or any of the excipients of the product as outlined in the IB.
3. Requires chronic immunosuppressive therapy (including steroids > 10 mg prednisone/day or equivalent)
4. 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
5. Undergone a major surgical procedure within 14 days to allow adequate healing
6. 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.
7. Known fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular malignant cholangiocarcinoma
8. Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS).
9. Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment.
10. Cardiac conditions as defined by the protocol.
11. History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention
12. Central nervous system (CNS) pathology or symptomatic or clinically unstable CNS metastases, as defined by the protocol, within 3 months prior to consent.
13. Infectious disease including active human immunodeficiency virus (HIV), and uncontrolled active systemic fungal, bacterial or other infection.
14. 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.
15. CAR-T cell therapy within the last 6 months prior to enrolment on this study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Incidence of DLTs (only for Dose Escalation).
2. Incidence of AEs, SAEs, and AESIs.
3. Objective Response Rate (ORR) (For dose expansion only)
4. AEs leading to discontinuation of AZD9793
5. Assess clinically significant alterations in vital signs and abnormal laboratory parameters

Secondary endpoints 12

1. Objective Response Rate (ORR) (For dose escalation only)
2. Best overall response (BOR)
3. Disease Control Rate (DCR) at 12 weeks
4. Durable response rate (DRR)
5. Duration of response (DoR)
6. Time To Response (TTR)
7. Change in target lesion (TL) tumour size
8. Progression free Survival (PFS)
9. Overall Survival (OS) [Dose expansion only]
10. Pharmacokinetics of AZD9793: Maximum serum concentration of the study drug (Cmax), serum concentrations of AZD9793, Area Under the concentration-time curve (AUC), Clearance, Terminal elimination half-life (t1/2)
11. Number and percentage of participants who develop anti-drug antibodies (ADAs) measured in serum
12. CD8+ T cell infiltration in tumours pre- and post- treatment measured by immunohistochemistry

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications