Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD8421 · 1 trial · 2 indications
Percentage of participants with incidence of DLTs.
Percentage of participants with incidence of AEs/SAEs.
Percentage of participants with clinically significant changes from baseline in clinical laboratory parameters, vital signs and ECGs.
Percentage of participants that have discontinued AZD8421 due to toxicity.
| Arm | Type | Description |
|---|---|---|
| Module 1 | EXPERIMENTAL | AZD8421 monotherapy |
| Module 2A | EXPERIMENTAL | AZD8421 with camizestrant and CDK4/6 inhibitor |
| Name | Type | Description |
|---|---|---|
| AZD8421 | DRUG | CDK2 inhibitor |
| Camizestrant | DRUG | SERD |
| Ribociclib | DRUG | CDK4/6 inhibitor |
| Palbociclib | DRUG | CDK4/6 inhibitor |
| Abemaciclib | DRUG | CDK4/6 inhibitor |
Inclusion Criteria: * Female participants only, aged 18 or above * Participants with advanced solid tumors must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease, or, in the opinion of the Investigator, a clinical study is the best opti...
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AZD8421 is an investigational small molecule being developed by AstraZeneca for ER+ HER2- advanced breast cancer and other selected advanced or metastatic solid tumors. It is in Phase 1 clinical development and is not yet approved for any indication.
AZD8421 is being studied for the treatment of ER+ HER2- advanced breast cancer, a form of breast cancer that expresses estrogen receptors but not HER2. It is also being evaluated in high-grade serous ovarian cancer. The drug remains investigational and has not been approved for any use.
AZD8421 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the ongoing first-in-human clinical study evaluating the compound in selected advanced or metastatic solid tumors.
AZD8421 is in Phase 1 clinical development. It is being evaluated in a first-in-human dose escalation and expansion study, and it is not FDA approved. The program remains investigational, with safety and tolerability as primary objectives in the ongoing trial.
AZD8421 is being studied in the Phase 1 trial NCT06188520, a first-in-human dose escalation and expansion study in participants with selected advanced or metastatic solid tumors, including ER+ HER2- advanced breast cancer and high-grade serous ovarian cancer. The trial is currently recruiting and has an enrollment of 564.
The Phase 1 trial NCT06188520 enrolls female participants aged 18 years and older with selected advanced or metastatic solid tumors, including ER+ HER2- advanced breast cancer and high-grade serous ovarian cancer. It is a biomarker-selected study and does not enroll healthy volunteers. Sites are in the United States, Australia, South Korea, Spain, and the United Kingdom.