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1

AVZO-023 Plus Hormone Therapy and an Experimental CDK2 Inhibitor for Advanced HR+, HER2- Breast Cancer

A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-023 as a Single Agent, and in Combination With AVZO-021 and/or Endocrine Therapy in Patients With Advanced Solid Tumors

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of AVZO-023 CDK4 inhibitor in combination with hormone therapy and an experimental CDK2 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. You must not have received CDK2, 4, and/or 6 inhibitors. You must not have active, untreated brain metastases. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023, by mouth</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023, by mouth</li> <li class="seamTextUnorderedListItem">AVZO-021, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023, by mouth</li> <li class="seamTextUnorderedListItem">AVZO-021, by mouth</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023 is an oral medication that inhibits cyclin-dependent kinase 4 (CDK4).</li> <li class="seamTextUnorderedListItem">AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK2). CDK inhibitors block enzymes that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone receptor positive breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06998407' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://avenzotx.com/pipeline-and-science/#moa' target='_blank'>Avenzo Therapeutics: AVZO-023</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: CDK4/6 Inhibitors</a> </li></ul>
1

AVZO-023 Plus Hormone Therapy and an Experimental CDK2 Inhibitor for Advanced HR+, HER2- Breast Cancer

A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-023 as a Single Agent, and in Combination With AVZO-021 and/or Endocrine Therapy in Patients With Advanced Solid Tumors
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Nearest Location:
336 miles
Avenzo Therapeutics Recruiting Site
Los Angeles, CA

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Visits:
Number of visits unavailable, up to 2 years

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ClinicalTrials.gov: NCT06998407

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Phase I-II

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