Recent Updates
Recently added Catalysts

AZD9150, Durvalumab

Phase 1

Advanced Solid Malignancies | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jun 24, 2019

Target and mechanism

ModalitySmall molecule

Also known as AZD9150

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

Clinical trial landscape

AZD9150, Durvalumab · 1 trial · 1 indication

Phase 1 1
NCT03394144Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid MalignanciesAdvanced Solid Malignancies
COMPLETED11 Analytics
PHASE1COMPLETED
Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies
Advanced Solid Malignancies
NCT0339414411
Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability in terms of adverse events
From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.

Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters

Secondary Endpoints

Maximum plasma concentration (Cmax)
From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.
Overall response rate
Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.
Duration of Response
Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
C1:AZD9150, C2:AZD9150+DurvalumabEXPERIMENTALAfter confirmed safety with Cohort 1, Cohort 2 will open

Interventions

NameTypeDescription
AZD9150, DurvalumabDRUGAfter confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to 120 Years
SexALL
Healthy VolunteersNo
Study Sites2

Key Inclusion Criteria: * Male and female patients must be at least 20 years of age. * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1. * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded...

Countries:Japan
Unlock Eligibility Criteria

Frequently asked questions about AZD9150, Durvalumab

What is AZD9150 used for?

AZD9150 is an investigational small molecule being studied for the treatment of advanced solid tumors, including advanced adult hepatocellular carcinoma, metastatic squamous cell carcinoma of the head and neck, and advanced solid malignancies. It is being evaluated in combination with other therapies in Phase 1 clinical trials.

Who makes AZD9150?

AZD9150 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical development for oncology indications.

What phase is AZD9150 in?

AZD9150 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for safety and efficacy in patients with advanced solid tumors.

What clinical trials is AZD9150 in?

AZD9150 has been studied in several completed Phase 1 clinical trials, including NCT01839604 in advanced hepatocellular carcinoma, NCT02499328 in advanced solid tumors and head and neck cancer, NCT03394144 in Japanese patients with advanced solid malignancies, and NCT03421353 in advanced solid tumors.

Is AZD9150 the same as ISIS-STAT3Rx?

Yes, AZD9150 is also known as ISIS-STAT3Rx, as indicated in the clinical trial title for NCT01839604. This alternative name reflects its earlier development by Ionis Pharmaceuticals before being studied by AstraZeneca.

How does AZD9150 work?

AZD9150 is a small molecule that targets STAT3, a protein involved in cancer cell growth and survival. By inhibiting STAT3, the drug aims to block tumor progression. It is being studied in combination with other cancer therapies in clinical trials.