Study on AZD8421 Alone or Combined with Other Drugs for Advanced or Metastatic Solid Tumors

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06188520

Provider View

This clinical trial is testing the safety and tolerability of a new drug, AZD8421, alone and in combination with other targeted cancer drugs in women with advanced breast cancer and metastatic ovarian cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and tolerability of AZD8421, a new drug, when used alone or with other targeted cancer drugs. The study focuses on women with advanced breast cancer that is ER+HER2- and those with metastatic high-grade serous ovarian cancer. Researchers aim to determine the best dose for future studies and assess how the drug behaves in the body.

Description

This is the first study to test AZD8421 in humans with advanced or metastatic solid tumors. The study will look at how safe and tolerable AZD8421 is, both on its own and when combined with other cancer drugs.

In one part of the study, AZD8421 will be given alone to see how it works in women with advanced breast cancer that is ER+HER2- and who have already been treated with a CDK4/6 inhibitor, as well as in women with metastatic high-grade serous ovarian cancer who have had platinum-based chemotherapy.

In another part, AZD8421 will be combined with a CDK4/6 inhibitor (such as abemaciclib, ribociclib, or palbociclib) and camizestrant, a next-generation oral drug, to see how this combination works in women with advanced breast cancer that is ER+HER2- and who have been treated with a CDK4/6 inhibitor.

Eligibility Criteria

Inclusion Criteria

  • Female participants only, aged 18 or above.
  • Must have advanced solid tumors and have received prior treatment according to local medical practices, or a clinical study is considered the best option by the doctor.
  • Must have cancer that has spread or returned and shows signs of progression after the last treatment.
  • Must be in good overall health with a performance status of 0 or 1 and a life expectancy of at least 12 weeks.
  • Must have at least one tumor that can be measured and assessed repeatedly.

Exclusion Criteria

  • Cannot have had certain cancer treatments or drugs within a specific time before starting the study.
  • Cannot take certain medications that affect the liver enzyme CYP3A4/5 during the study.
  • Cannot have had recent major surgery or significant injury.
  • Cannot have unresolved side effects from previous cancer treatments, except for hair loss.
  • Cannot have severe or uncontrolled diseases, including certain heart conditions or infections.
  • Cannot have a history of severe allergic reactions to similar drugs.
  • Cannot be pregnant, breastfeeding, or planning to become pregnant. Must agree to use effective contraception if of childbearing potential.

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