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

NCT ID: NCT05080842

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-12
• Study Completion Date: 2024-04-04

Brief 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

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AC682

This arm will evaluate AC682 monotherapy administered in 28-day cycles. Up to 30 participants will participate in this dose escalation arm.

Group Type: EXPERIMENTAL

AC682

Intervention Type: DRUG

Participants will receive AC682 by mouth daily in 28-day cycles.

Interventions

AC682

Participants will receive AC682 by mouth daily in 28-day cycles.

Intervention Type: DRUG

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 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Accutar Biotechnology Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Site 01

Denver, Colorado, United States

Site 04

Orlando, Florida, United States

Site 02

Sarasota, Florida, United States

Site 03

Nashville, Tennessee, United States

Site 05

Houston, Texas, United States

Countries

United States

Other Identifiers

AC682-001

Identifier Type: -

Identifier Source: org_study_id