Status and phase
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About
This clinical trial is evaluating AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. The main goals of this study are to:
Full description
This is a Phase I, open-label dose-escalation study of AC682, an orally available estrogen receptor degrader, given as a single agent.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Treatment with any of the following:
systemic anti-cancer chemotherapy, biologic, or hormonal agent from a previous treatment regimen or clinical study within 4 weeks prior to the first dose of AC682; systemic small molecules from a previous treatment regimen or clinical study within 14 days or 5 half-lives (whichever is longer) prior to the first dose of AC682 (at least 10 days must have elapsed between the last dose of such agent and the first dose of study drug)
Received radiotherapy (including radioactive isotope therapy) within 4 weeks prior to the first dose of AC682
Major surgery (excluding placement of vascular access) within 4 weeks of first dose of AC682
With known metastasis to the brain
Any condition that impairs a patient's ability to swallow whole pills. Impairment of gastrointestinal function (GI) or GI disease or other condition at baseline that will interfere significantly with the absorption, distribution, or metabolism of AC682.
Use of prophylactic growth factors and blood transfusions ≤14 days prior to the first dose of AC682 and during dose limiting toxicity observation period
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
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Central trial contact
Accutar Biotechnology
Data sourced from clinicaltrials.gov
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