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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05080842
• Other study ID #: AC682-001
• Status: Terminated
• Phase: Phase 1
• Start date: November 12, 2021
• Est. completion date: April 4, 2024

Study information

• Verified date: April 2024
• Source: Accutar Biotechnology Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: April 4, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Site 01	Denver	Colorado
United States	Site 05	Houston	Texas
United States	Site 03	Nashville	Tennessee
United States	Site 04	Orlando	Florida
United States	Site 02	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Accutar Biotechnology Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose limiting toxicities (DLTs)		28 days (Cycle 1)
Primary	Incidence of treatment-emergent adverse events (TEAEs), and clinically significant grade 3 or higher laboratory abnormalities following administration of AC682	Adverse events will be graded according to NCI CTCAE v5.0.	Through study completion, approximately 18 months
Secondary	Objective response rate (ORR) as a measure of anti-tumor activity		Through study completion, approximately 18 months
Secondary	Clinical benefit rate (CBR) as a measure of anti-tumor activity		Through study completion, approximately 18 months
Secondary	Duration of response (DOR) as a measure of anti-tumor activity		Through study completion, approximately 18 months
Secondary	Disease control rate (DCR) as a measure of anti-tumor activity		Through study completion, approximately 18 months
Secondary	Progression free survival (PFS) as a measure of anti-tumor activity		Through study completion, approximately 18 months
Secondary	Pharmacokinetic Analysis: area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf))		Through study completion, approximately 18 months
Secondary	Pharmacokinetic Analysis: area under the concentration-time curve over the dosing interval (AUC(0-tau))		Through study completion, approximately 18 months
Secondary	Pharmacokinetic Analysis: maximum plasma concentration (Cmax)		Through study completion, approximately 18 months
Secondary	Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)		Through study completion, approximately 18 months
Secondary	Pharmacokinetic Analysis: terminal elimination half life (t1/2)		Through study completion, approximately 18 months