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

NCT05080842 | Terminated Phase 1 FDA Drug

• 1 other identifier: AC682-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 5

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

Conditions

Breast Cancer

Keywords

Estrogen receptor positive; ER positive; ER+; Human epidermal growth factor receptor 2 negative; HER2 negative; HER2-; AC682; Breast cancer; Phase I

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicities (DLTs)

  28 days (Cycle 1)

• 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 Outcomes (10)

• Objective response rate (ORR) as a measure of anti-tumor activity

  Through study completion, approximately 18 months

• Clinical benefit rate (CBR) as a measure of anti-tumor activity

  Through study completion, approximately 18 months

• Duration of response (DOR) as a measure of anti-tumor activity

  Through study completion, approximately 18 months

• Disease control rate (DCR) as a measure of anti-tumor activity

  Through study completion, approximately 18 months

• Progression free survival (PFS) as a measure of anti-tumor activity

  Through study completion, approximately 18 months

Study Arms (1)

AC682

EXPERIMENTAL

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

Drug: AC682

Interventions

AC682 DRUG

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

AC682

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Accutar Biotechnology Inc: lead

Study Sites (5)

Site 01

Denver, Colorado, 80218, United States

Location

Site 04

Orlando, Florida, 32827, United States

Location

Site 02

Sarasota, Florida, 34232, United States

Location

Site 03

Nashville, Tennessee, 37203, United States

Location

Site 05

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 18, 2021
• Study Start: November 12, 2021
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)