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Azd8421

This article discusses a groundbreaking clinical trial investigating the use of AZD8421, a new drug being tested for treating advanced or metastatic solid tumors. The study focuses on patients with ER+HER2- advanced breast cancer and high-grade serous ovarian cancer. The trial aims to assess the safety, effectiveness, and how the body processes AZD8421 when used alone or in combination with other cancer drugs.

Table of Contents

What is AZD8421?

AZD8421 is a new drug currently being studied for its potential in treating certain types of advanced cancers. It is classified as a CDK2 inhibitor, which means it targets a specific protein in cancer cells involved in cell division[1]. This drug is still in the early stages of research and is not yet approved for general use.

Target Conditions

The clinical trial is focusing on two main types of cancer[1]:

  • ER+ HER2- Advanced Breast Cancer: This is a type of breast cancer that is estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-). “Advanced” means the cancer has spread beyond the breast to other parts of the body.
  • High-grade Serous Ovarian Cancer (HGSOC): This is an aggressive form of ovarian cancer that has spread to other parts of the body (metastatic).

How AZD8421 Works

AZD8421 is designed to inhibit CDK2, a protein that plays a crucial role in cell division. By targeting this protein, the drug aims to slow down or stop the growth of cancer cells[1]. This approach is particularly promising for cancers that have become resistant to other treatments.

Clinical Trial Overview

The current study of AZD8421 is a Phase I/IIa clinical trial, which means it’s one of the earliest stages of testing in humans[1]. The main goals of this trial are:

  • To evaluate the safety and tolerability of AZD8421
  • To determine the best dose for future studies
  • To assess how the drug behaves in the body (pharmacokinetics)
  • To look for early signs of effectiveness against cancer

Combination Therapies

The trial is not only testing AZD8421 by itself but also in combination with other cancer drugs[1]:

  • Camizestrant (also known as AZD9833): This is a type of drug called a SERD (Selective Estrogen Receptor Degrader), which targets estrogen receptors in breast cancer cells.
  • CDK4/6 inhibitors: These are drugs that target different proteins involved in cell division. The trial is testing AZD8421 with one or more of the following:
    • Abemaciclib (also known as Verzenios)
    • Ribociclib (also known as Kisqali)
    • Palbociclib (also known as Ibrance)

Safety and Efficacy Measures

The researchers are closely monitoring several aspects to ensure patient safety and evaluate the drug’s effectiveness[1]:

  • Side effects and serious adverse events
  • Changes in laboratory tests, vital signs, and heart activity (ECGs)
  • How well tumors respond to the treatment (e.g., if they shrink or stop growing)
  • How long patients live without their cancer getting worse (progression-free survival)
  • Overall survival rates

Pharmacokinetics

The study is also looking at how AZD8421 behaves in the body, including[1]:

  • How quickly the drug reaches its maximum concentration in the blood
  • How long it stays in the body
  • How the body processes and eliminates the drug
This information helps researchers understand how to best administer the drug for maximum effectiveness and safety.

Potential Benefits

While it’s too early to know for sure, researchers hope that AZD8421 might offer several potential benefits[1]:

  • A new treatment option for patients whose cancer has become resistant to other therapies
  • Possible improved outcomes when combined with existing cancer drugs
  • A targeted approach that may have fewer side effects than traditional chemotherapy
It’s important to remember that as this is an early-stage trial, more research will be needed to fully understand the benefits and risks of AZD8421.

Aspect Details
Study Type Phase I/IIa, first-in-human, open-label, dose escalation and expansion study
Drug AZD8421 (CDK2 inhibitor)
Target Conditions ER+HER2- advanced breast cancer, high-grade serous ovarian cancer
Study Arms 1. AZD8421 monotherapy 2. AZD8421 with camizestrant and abemaciclib 3. AZD8421 with camizestrant and ribociclib 4. AZD8421 with camizestrant and palbociclib
Primary Outcomes Safety and tolerability (DLTs, AEs/SAEs, lab parameters, discontinuation rate)
Secondary Outcomes Efficacy (ORR, DoR, DCR, PFS, OS), pharmacokinetics, pharmacodynamics
Study Duration Approximately 18 months

FAQ

  • What is AZD8421 and what types of cancer is it being tested for? AZD8421 is a CDK2 inhibitor being tested for treating advanced or metastatic solid tumors. The trial specifically focuses on patients with ER+HER2- advanced breast cancer and high-grade serous ovarian cancer.
  • What is the main goal of this clinical trial? The main goal is to evaluate the safety, tolerability, and preliminary effectiveness of AZD8421. The study also aims to understand how the body processes the drug (pharmacokinetics) and its effects on the body (pharmacodynamics).
  • Is AZD8421 being tested alone or in combination with other drugs? AZD8421 is being tested both as a monotherapy (alone) and in combination with other targeted anti-cancer drugs, including CDK4/6 inhibitors (such as abemaciclib, ribociclib, and palbociclib) and camizestrant (a next-generation oral SERD).
  • What are the primary outcomes being measured in this trial? The primary outcomes include the incidence of dose-limiting toxicities, adverse events, changes in clinical laboratory parameters, vital signs, and ECGs, and the rate of discontinuation due to toxicity.
  • How long is the study expected to last? The study is expected to last approximately 18 months, during which participants will be monitored for safety and efficacy outcomes.

Ongoing Clinical Trials on Azd8421

  • Study on the Safety of AZD8421 Alone or with Drug Combination for Patients with Advanced Breast Cancer and High-Grade Ovarian Cancer

    Recruiting

    1 1 1
    Investigated drugs:
    Spain

Glossary

  • CDK2 inhibitor: A type of drug that blocks the action of cyclin-dependent kinase 2, an enzyme involved in cell division. CDK2 inhibitors may help slow or stop the growth of cancer cells.
  • ER+HER2- breast cancer: A type of breast cancer that is estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-). This means the cancer cells grow in response to estrogen but do not have high levels of HER2 protein.
  • High-grade serous ovarian cancer (HGSOC): An aggressive form of ovarian cancer that develops in the cells lining the ovaries or fallopian tubes. It is called 'high-grade' because the cancer cells look very abnormal under a microscope.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it is absorbed, distributed, metabolized, and excreted.
  • Pharmacodynamics (PD): The study of how a drug affects the body, including its mechanism of action and the relationship between drug concentration and effect.
  • CDK4/6 inhibitor: A class of drugs that block cyclin-dependent kinases 4 and 6, which are involved in cell division. These inhibitors are used to treat certain types of breast cancer.
  • SERD: Selective Estrogen Receptor Degrader, a type of drug that blocks and degrades estrogen receptors in cancer cells, potentially slowing or stopping their growth.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dosage or require a reduction in dosage.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious adverse event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, causes persistent or significant disability, or results in birth defects.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to assess how well a cancer patient responds to treatment based on changes in tumor size.
  • Monotherapy: Treatment using a single drug.
  • Combination therapy: Treatment using two or more drugs or treatment modalities.

References

  1. https://clinicaltrials.gov/study/NCT06188520