Breast Cancer Clinical Trial

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

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

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Full Description

This is a Phase I, first in human, open-label dose-escalation study of AC682, an orally available estrogen receptor degrader, given as a single agent.

View Eligibility Criteria

Eligibility Criteria

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 according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or at least 1 predominantly lytic bone lesion in the absence of measurable disease

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 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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05080842

Recruitment Status:

Recruiting

Sponsor:

Accutar Biotechnology Inc

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There are 5 Locations for this study

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Site 01
Denver Colorado, 80218, United States
Site 04
Orlando Florida, 32827, United States
Site 02
Sarasota Florida, 34232, United States
Site 03
Nashville Tennessee, 37203, United States
Site 05
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05080842

Recruitment Status:

Recruiting

Sponsor:


Accutar Biotechnology Inc

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