Title: A phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of AC699 in patients with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer
Responsible Party: Accutar Biotechnology, Inc.
Description: Researchers are conducting a phase 1 trial to test the safety and efficacy of AC699 in patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer.
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In this dose-escalation trial, patients will receive varying doses of oral AC699 daily in 28-day cycles.
The primary outcomes are dose-limiting toxicities and the incidence of adverse events or grade 3 or higher lab abnormalities. Secondary outcomes include objective response rate, clinical benefit rate, duration of response, disease control rate, progression-free survival, and pharmacokinetics.
To be eligible for this study, patients must be 18 years of age or older, and female patients must be postmenopausal. Patients must have a histologically or cytologically confirmed diagnosis of ER-positive, HER2-negative, advanced, unresectable, and/or metastatic breast cancer.
Patients must have received at least 2 prior endocrine therapies or at least 1 prior line of endocrine therapy if combined with a CDK4/6 inhibitor. Patients must have had disease progression on standard treatment, not be amenable to standard treatment, or have no therapies with proven efficacy available to them. For a complete list of eligibility criteria, please see the reference.
Status: Recruiting
This study is sponsored by Accutar Biotechnology, Inc.
Reference
ClinicalTrials.gov. Study of AC699 in patients with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. NCT05654532. Accessed February 21, 2023.
