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

NCT06795022 | Recruiting Phase 1 FDA Drug

• 1 other identifier: D7040C00001
• Study Type: interventional
• Target: 304
• Locations: 7 countries
• Sites: 20

Brief 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+.

Conditions

Hepatocellular Carcinoma

Keywords

Glypican-3; GPC3; GPC3+ tumours; T cell-engaging antibody; TCE; AZD9793; Solid tumours; HCC

Outcome Measures

Primary Outcomes (5)

• The number of patients with adverse events

  Number of patients with adverse events by system organ class and preferred term

  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

  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

  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.

  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 Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation.

  From date of first dose of study drug until the end of Cycle 1 (up to 28 days)

• Objective Response Rate (ORR) [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.

  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 (14)

• Objective Response Rate (ORR) [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)

• Disease Control Rate (DCR) at 12 weeks

  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)

  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)

• 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)

Study Arms (2)

Module 1: AZD9793 Intravenous (IV) monotherapy

EXPERIMENTAL

Module 1: AZD9793 Intravenous (IV) monotherapy

Drug: AZD9793 Intravenous (IV) monotherapy

Module 2: AZD9793 Subcutaneous (SC) monotherapy

EXPERIMENTAL

Module 2: AZD9793 Subcutaneous (SC) monotherapy

Drug: AZD9793 Subcutaneous (SC) monotherapy)

Interventions

AZD9793 Intravenous (IV) monotherapy DRUG

T cell-engaging antibody that targets GPC3 on tumour cells

Module 1: AZD9793 Intravenous (IV) monotherapy

AZD9793 Subcutaneous (SC) monotherapy) DRUG

T cell-engaging antibody that targets GPC3 on tumour cells

Module 2: AZD9793 Subcutaneous (SC) monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• Prior treatment with any therapy that is targeted to GPC3.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (20)

Research Site

La Jolla, California, 92093, United States

NOT YET RECRUITING

Research Site

Los Angeles, California, 90089, United States

NOT YET RECRUITING

Research Site

Baltimore, Maryland, 21201, United States

NOT YET RECRUITING

Research Site

St Louis, Missouri, 63108, United States

RECRUITING

Research Site

Hackensack, New Jersey, 07601, United States

NOT YET RECRUITING

Research Site

Houston, Texas, 77030, United States

RECRUITING

Research Site

Chengdu, 610041, China

NOT YET RECRUITING

Research Site

Guangzhou, 510515, China

NOT YET RECRUITING

Research Site

Harbin, 150049, China

NOT YET RECRUITING

Research Site

Shanghai, 201114, China

NOT YET RECRUITING

Research Site

Pokfulam, 999077, Hong Kong

NOT YET RECRUITING

Research Site

Shatin, 000000, Hong Kong

RECRUITING

Research Site

Kashiwa, 277-8577, Japan

RECRUITING

Research Site

Yokohama, 241-8515, Japan

RECRUITING

Research Site

Seoul, 06351, South Korea

NOT YET RECRUITING

Research Site

Seoul, 5505, South Korea

RECRUITING

Research Site

Barcelona, 8035, Spain

NOT YET RECRUITING

Research Site

Pamplona, 31008, Spain

NOT YET RECRUITING

Research Site

Taipei, 10002, Taiwan

RECRUITING

Research Site

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Simpson-Golabi-Behmel syndrome

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 27, 2025
• Study Start: March 27, 2025
• Primary Completion (Estimated): February 25, 2028
• Study Completion (Estimated): July 25, 2028
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

CN (4); HK (2); JP (2); KR (2); TW (2); ES (2); US (6)