TerminatedPhase 1

A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer

Stopped: Voluntarily terminate the study since the sponsor's development strategy was adjusted.

United States21 participantsStarted 2021-11-12

Plain-language summary

This clinical trial is evaluating a drug called 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: * Identify the recommended dose of AC682 that can be given safely to participants * To evaluate the side effects of AC682 * To evaluate pharmacokinetics of AC682 * To evaluate the effectiveness of AC682

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed written informed consent form (ICF) * Patients must be ≥18 years-of-age at the time of signing of the ICF * Female patients must be postmenopausal * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Histologically and/or cytologically confirmed advanced estrogen receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer * Patients with life expectancy ≥3 months * Patients who have adequate organ functions at baseline * At least 1 measurable lesion that meets the definition in Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or at least 1 non-target lesion is required. 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) * Radiation therapy such as wide-field radiotherapy administered ≤28 days of first dose of AC682 * Major surgery (excluding placement of vascular access) within 4 weeks of first dose of AC682 * Known symptomatic brain metastases requiring the use of steroids * Any condition that impairs a patient's ability to swallow whole pi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of dose limiting toxicities (DLTs)

Timeframe: 28 days (Cycle 1)

Incidence of treatment-emergent adverse events (TEAEs), and clinically significant grade 3 or higher laboratory abnormalities following administration of AC682

Timeframe: Through study completion, approximately 18 months

Trial details

NCT IDNCT05080842

SponsorAccutar Biotechnology Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-04

View on ClinicalTrials.gov More Breast Cancer trials