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

Sponsor

Accutar Biotechnology Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05080842

Collaborator

(none)

Enrollment

Locations

Arm

21.6

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: AC682	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 12, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AC682 This arm will evaluate AC682 monotherapy administered in 28-day cycles. Up to 30 participants will participate in this dose escalation arm.	Drug: AC682 Participants will receive AC682 by mouth daily in 28-day cycles.

Arm

Intervention/Treatment

Experimental: AC682

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

Drug: AC682

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

Outcome Measures

Primary Outcome Measures

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 [Through study completion, approximately 18 months]
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 [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]
Pharmacokinetic Analysis: area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf)) [Through study completion, approximately 18 months]
Pharmacokinetic Analysis: area under the concentration-time curve over the dosing interval (AUC(0-tau)) [Through study completion, approximately 18 months]
Pharmacokinetic Analysis: maximum plasma concentration (Cmax) [Through study completion, approximately 18 months]
Pharmacokinetic Analysis: time to maximum plasma concentration (tmax) [Through study completion, approximately 18 months]
Pharmacokinetic Analysis: terminal elimination half life (t1/2) [Through study completion, approximately 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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