NCT05654532

Study of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Accutar Biotechnology Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is evaluating a drug called AC699 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 AC699 that can be given safely to participants * Evaluate the safety profile of AC699 * Evaluate the pharmacokinetics of AC699 * Evaluate the effectiveness of AC699

Detailed description

This study is a Phase I, first-in-human, open-label dose-escalation study of AC699, an orally bioavailable estrogen receptor degrader, given as a single agent.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	AC699	Participants will receive AC699 orally daily in 28-day cycles.

Timeline

• Start date: 2022-12-29
• Primary completion: 2026-03-31
• Completion: 2026-05-31
• First posted: 2022-12-16
• Last updated: 2025-09-30

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study