NCT05080842

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

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC682 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Accutar Biotechnology Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	AC682	Participants will receive AC682 by mouth daily in 28-day cycles.

Timeline

• Start date: 2021-11-12
• Primary completion: 2024-04-04
• Completion: 2024-04-04
• First posted: 2021-10-18
• Last updated: 2025-02-13

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study