RecruitingPhase 1Phase 2NCT06188520

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

A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors


Sponsor

AstraZeneca

Enrollment

564 participants

Start Date

Dec 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This first-in-human study tests a new experimental drug called AZD8421 — alone or in combination with other treatments — in women with advanced or metastatic solid tumors. The primary goal is to assess safety and find the right dose. **You may be eligible if...** - You are a woman aged 18 or older - You have an advanced solid tumor (cancer that has spread and does not respond to standard treatment, or where a clinical trial is the best option) - You have received prior standard-of-care treatment for your cancer type - Your overall health meets required standards **You may NOT be eligible if...** - You are male (this trial enrolls female participants only) - You have active brain metastases that are untreated or unstable - You have serious heart, liver, or kidney conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD8421

CDK2 inhibitor

DRUGCamizestrant

SERD

DRUGRibociclib

CDK4/6 inhibitor

DRUGPalbociclib

CDK4/6 inhibitor

DRUGAbemaciclib

CDK4/6 inhibitor


Locations(14)

Research Site

St Louis, Missouri, United States

Research Site

Providence, Rhode Island, United States

Research Site

Nashville, Tennessee, United States

Research Site

Houston, Texas, United States

Research Site

East Melbourne, Australia

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Barcelona, Spain

Research Site

Pamplona, Spain

Research Site

Valencia, Spain

Research Site

Cambridge, United Kingdom

Research Site

Leeds, United Kingdom

Research Site

London, United Kingdom

Research Site

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06188520