Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD9793 Intravenous (IV) monotherapy, AZD9793 monotherapy
AZD9793 · 1 trial · 1 indication
Number of patients with adverse events by system organ class and preferred term
Number of patients with serious adverse events by system organ class and preferred term
Number of patients with adverse events of special interest by system organ class and preferred term
Number of AEs that in the opinion of the Investigator or the Sponsor contraindicate further dosing or AEs that meet criteria for discontinuation
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.
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.
| Arm | Type | Description |
|---|---|---|
| Module 1: AZD9793 Intravenous (IV) monotherapy Part A | EXPERIMENTAL | Module 1: AZD9793 Intravenous (IV) monotherapy Part A: Dose Escalation |
| Module 2: AZD9793 Subcutaneous (SC) monotherapy Part A | EXPERIMENTAL | Module 2: AZD9793 Subcutaneous (SC) monotherapy Part A: Dose Escalation |
| Module 1: AZD9793 Intravenous (IV) monotherapy Part B | EXPERIMENTAL | Module 1: AZD9793 Intravenous (IV) monotherapy Part B: Dose Expansion |
| Module 2: AZD9793 Subcutaneous (SC) monotherapy Part B | EXPERIMENTAL | Module 2: AZD9793 Subcutaneous (SC) monotherapy Part B: Dose Expansion |
| Name | Type | Description |
|---|---|---|
| AZD9793 Intravenous (IV) monotherapy | DRUG | T cell-engaging antibody that targets GPC3 on tumour cells |
| AZD9793 Subcutaneous (SC) monotherapy | DRUG | T cell-engaging antibody that targets GPC3 on tumour cells |
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 ...
AZD9793 is an investigational small molecule being studied for the treatment of hepatocellular carcinoma, a form of liver cancer. It is being evaluated in patients with advanced or metastatic solid tumors, with hepatocellular carcinoma as the condition under study. AZD9793 has not been approved for any use and remains in clinical development.
AZD9793 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the first-in-human study evaluating AZD9793 in participants with advanced or metastatic solid tumors, including hepatocellular carcinoma.
AZD9793 is in Phase 1 clinical development. It is being evaluated in a first-in-human study in participants with advanced or metastatic solid tumors. As a Phase 1 investigational agent, AZD9793 has not received FDA approval and is not yet available as a marketed therapy.
AZD9793 is being studied in one active clinical trial, NCT06795022, titled a First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours. The trial is currently recruiting, has an enrollment of 304 participants, and is being conducted in the United States, China, Hong Kong, Japan, South Korea, Spain, and Taiwan.
Yes, AZD9793 Intravenous (IV) monotherapy and AZD9793 monotherapy are alternative names for AZD9793. These names refer to the same investigational small molecule developed by AstraZeneca PLC for hepatocellular carcinoma and other advanced or metastatic solid tumors.