Clinical trial NCT05080842: 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
Overall status: TERMINATED
Phase: PHASE1
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
Lead sponsor: Accutar Biotechnology Inc
Sponsor class: INDUSTRY
First posted: 2021-10-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of dose limiting toxicities (DLTs)
timeFrame: 28 days (Cycle 1)
measure: Incidence of treatment-emergent adverse events (TEAEs), and clinically significant grade 3 or higher laboratory abnormalities following administration of AC682
timeFrame: Through study completion, approximately 18 months
Secondary outcomes:
measure: Objective response rate (ORR) as a measure of anti-tumor activity
timeFrame: Through study completion, approximately 18 months
measure: Clinical benefit rate (CBR) as a measure of anti-tumor activity
timeFrame: Through study completion, approximately 18 months
measure: Duration of response (DOR) as a measure of anti-tumor activity
timeFrame: Through study completion, approximately 18 months
measure: Disease control rate (DCR) as a measure of anti-tumor activity
timeFrame: Through study completion, approximately 18 months
measure: Progression free survival (PFS) as a measure of anti-tumor activity
timeFrame: Through study completion, approximately 18 months
measure: Pharmacokinetic Analysis: area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf))
timeFrame: Through study completion, approximately 18 months
measure: Pharmacokinetic Analysis: area under the concentration-time curve over the dosing interval (AUC(0-tau))
timeFrame: Through study completion, approximately 18 months
measure: Pharmacokinetic Analysis: maximum plasma concentration (Cmax)
timeFrame: Through study completion, approximately 18 months
measure: Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)
timeFrame: Through study completion, approximately 18 months
measure: Pharmacokinetic Analysis: terminal elimination half life (t1/2)
timeFrame: Through study completion, approximately 18 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Site 01
state: Colorado
city: Orlando
country: United States
facility: Site 04
state: Florida
city: Sarasota
country: United States
facility: Site 02
state: Florida
city: Nashville
country: United States
facility: Site 03
state: Tennessee
city: Houston
country: United States
facility: Site 05
state: Texas
Study officials:
References: