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

Primary Purpose

Breast Cancer

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AC682

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Estrogen receptor positive, ER positive, ER+, Human epidermal growth factor receptor 2 negative, HER2 negative, HER2-, AC682, Breast cancer, Phase I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or at least 1 predominantly lytic bone lesion in the absence of measurable disease

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

Sites / Locations

Site 01
Site 04
Site 02
Site 03
Site 05

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AC682

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of dose limiting toxicities (DLTs)

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.

Secondary Outcome Measures

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

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

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

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

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

Pharmacokinetic Analysis: area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf))

Pharmacokinetic Analysis: area under the concentration-time curve over the dosing interval (AUC(0-tau))

Pharmacokinetic Analysis: maximum plasma concentration (Cmax)

Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)

Pharmacokinetic Analysis: terminal elimination half life (t1/2)

Full Information

NCT ID

NCT05080842

First Posted

September 22, 2021

Last Updated

October 24, 2023

Sponsor

Accutar Biotechnology Inc

1. Study Identification

Unique Protocol Identification Number

NCT05080842

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 12, 2021 (Actual)

Primary Completion Date

January 30, 2024 (Anticipated)

Study Completion Date

February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Accutar Biotechnology Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AC682

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AC682

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of dose limiting toxicities (DLTs)

Time Frame

28 days (Cycle 1)

Title

Incidence of treatment-emergent adverse events (TEAEs), and clinically significant grade 3 or higher laboratory abnormalities following administration of AC682

Description

Adverse events will be graded according to NCI CTCAE v5.0.

Time Frame