AC0682 / Accutar Biotech - LARVOL DELTA

A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer (clinicaltrials.gov) - P1 | N=21 | Terminated | Sponsor: Accutar Biotechnology Inc | N=30 ➔ 21 | Trial completion date: Dec 2024 ➔ Apr 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ Apr 2024; Voluntarily terminate the study since the sponsor's development strategy was adjusted.

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Accutar Biotechnology Inc | Trial completion date: Feb 2024 ➔ Dec 2024 | Trial primary completion date: Jan 2024 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=6 | Terminated | Sponsor: Accutar Biotechnology Inc | Trial completion date: Dec 2024 ➔ Sep 2023 | Active, not recruiting ➔ Terminated; Voluntarily terminate the study since the sponsor's development strategy was adjusted.

Metastases • Trial completion date • Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Accutar Biotechnology Inc | Recruiting ➔ Active, not recruiting | N=150 ➔ 6 | Trial primary completion date: Jul 2023 ➔ Dec 2023

Enrollment change • Enrollment closed • Metastases • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Accutar Biotechnology Inc | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2023 ➔ Feb 2024 | Trial primary completion date: Jun 2023 ➔ Jan 2024

Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Accutar Biotechnology Inc | Trial primary completion date: Sep 2022 ➔ Jun 2023

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Accutar Biotechnology Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Accutar Biotechnology Announces First Patient Dosed in China with AC0682 in Phase 1 Study in ER-Positive Breast Cancer (Businesswire) - "Accutar Biotechnology, Inc...announces the dosing of the first patient in China in a Phase 1 study of AC0682, an orally bioavailable chimeric degrader molecule designed to target ERα protein with high potency and selectivity....The Phase 1 study in China will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0682 treatment in Chinese patients with ER-positive breast cancer."

Trial status • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Accutar Biotechnology Inc

New P1 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Accutar Biotechnology Receives NMPA Clearance of IND Application for AC0682 in ER-Positive Breast Cancer (Businesswire) - "Accutar Biotechnology, Inc...announces that the China National Medical Products Administration (NMPA) has cleared the company’s investigational new drug application (IND) for AC0682 for the treatment of patients with estrogen receptor (ER)-positive breast cancers....The Phase 1 study in China will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0682 treatment in Chinese patients with ER-positive breast cancer. Accutar expects to begin enrollment of this study in the second half of this year."

New P1 trial • Breast Cancer • Oncology • Solid Tumor

A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Accutar Biotechnology Inc; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Accutar Biotechnology Announces First Patient Dosed with AC0682 in Phase 1 Study in Patients with ER-Positive / HER2-Negative Locally Advanced or Metastatic Breast Cancer (Businesswire) - "Accutar Biotechnology, Inc...announced the dose administration for the first patient in a Phase 1 study of AC0682, an orally bioavailable, chimeric degrader molecule designed to target and degrade ERα protein with high potency and selectivity....The purpose of the Phase 1 multi-center, open-label study is to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0682 treatment in patients with ER-positive / HER2-negative locally advanced or metastatic breast cancer."

Trial status • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer (clinicaltrials.gov) - P1; N=42; Not yet recruiting; Sponsor: Accutar Biotechnology Inc

Clinical • New P1 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Accutar Biotechnology Announces FDA Clearance of IND Application for Phase 1 Trial of AC0682 in ER-Positive Breast Cancer (Businesswire) - "Accutar Biotechnology, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for AC0682 for the treatment of patients with estrogen receptor (ER)-positive breast cancers....'Treatment options are limited for patients with metastatic ER+ breast cancer after hormonal and CDK4/6 inhibitor treatment,' said Dr. Erika Hamilton..."

Media quote • Regulatory