Trials Sponsors Conditions Drugs Pricing

Conditions

Hepatocellular Carcinoma

Keywords

Glypican-3GPC3GPC3+ tumoursT cell-engaging antibodyTCEAZD9793Solid tumoursHCC

Outcome Measures

Primary Outcomes (6)

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 AEs leading to discontinuation of AZD9793

Secondary Outcomes (15)

Objective Response Rate (ORR) [Part A 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)
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)
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)

Study Arms (4)

Module 1: AZD9793 Intravenous (IV) monotherapy Part A

EXPERIMENTAL

Module 1: AZD9793 Intravenous (IV) monotherapy Part A: Dose Escalation

Drug: AZD9793 Intravenous (IV) monotherapy

Module 2: AZD9793 Subcutaneous (SC) monotherapy Part A

EXPERIMENTAL

Module 2: AZD9793 Subcutaneous (SC) monotherapy Part A: Dose Escalation

Drug: AZD9793 Subcutaneous (SC) monotherapy

Module 1: AZD9793 Intravenous (IV) monotherapy Part B

EXPERIMENTAL

Module 1: AZD9793 Intravenous (IV) monotherapy Part B: Dose Expansion

Interventions

AZD9793 Intravenous (IV) monotherapyDrug

T cell-engaging antibody that targets GPC3 on tumour cells

Module 1: AZD9793 Intravenous (IV) monotherapy Part AModule 1: AZD9793 Intravenous (IV) monotherapy Part B

AZD9793 Subcutaneous (SC) monotherapyDrug

T cell-engaging antibody that targets GPC3 on tumour cells

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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. 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.

Sponsors & Collaborators

AstraZeneca AB
Industrylead
AstraZeneca
Industrylead

Study Sites (21)

Research Site

La Jolla, California, 92093, United States

WITHDRAWN

Research Site

Los Angeles, California, 90089, United States

RECRUITING

Research Site

Baltimore, Maryland, 21201, United States

NOT_YET_RECRUITING

Research Site

Boston, Massachusetts, 02114, United States

MeSH Terms

Conditions

Carcinoma, HepatocellularSimpson-Golabi-Behmel syndrome

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver 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 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 27, 2025

Study Start

March 27, 2025

Actual (reported)

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).
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.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (15)

Study Arms (4)

Module 1: AZD9793 Intravenous (IV) monotherapy Part A

Module 2: AZD9793 Subcutaneous (SC) monotherapy Part A

Module 1: AZD9793 Intravenous (IV) monotherapy Part B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Module 2: AZD9793 Subcutaneous (SC) monotherapy Part B

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (15)

Study Arms (4)

Module 1: AZD9793 Intravenous (IV) monotherapy Part A

Module 2: AZD9793 Subcutaneous (SC) monotherapy Part A

Module 1: AZD9793 Intravenous (IV) monotherapy Part B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Module 2: AZD9793 Subcutaneous (SC) monotherapy Part B

You may not qualify if:

Data Sharing

Source records

Locations