A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
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Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
564estimated
Sites
14
Countries
Australia, South Korea, Spain +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-12-05 | actual | When the study began enrolling |
| Primary completion | 2027-08-04 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-08-04 | estimated | The whole study's end, after follow-up |
| First posted | 2024-01-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- ER+ HER2- Advanced Breast Cancer
- High-grade Serous Ovarian Cancer (HGSOC)
Interventions
- Drug: AZD8421
- Drug: Camizestrant — also filed as AZD9833
- Drug: Ribociclib — also filed as Kisqali
- Drug: Palbociclib — also filed as Ibrance
- Drug: Abemaciclib — also filed as Verzenios
Primary outcomes
what the primary-completion date above is the date OFIncidence of dose limiting toxicities (DLTs) as defined in the protocol.
measured From start of treatment until the end of DLT period, assessed up to 28 days.
Incidence of AEs/SAEs
measured From start of treatment until the end of safety follow-up, approximately 18 months.
Clinically significant changes from baseline in clinical laboratory parameters, vital signs and ECGs.
measured From start of treatment until the end of safety follow-up, approximately 18 months.
Discontinuation of AZD8421 due to toxicity
measured From start of treatment until the end of safety follow-up, approximately 18 months.
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