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A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Phase 1

Locations

China

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, AC682, Phase I

Eligibility Criteria

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

Inclusion Criteria:

Patients must be ≥18 years-of-age at the time of signing of the ICF
Histologically and/or cytologically confirmed advanced estrogen receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer
Female patients must be postmenopausal
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
Previously received at least 1 endocrine therapy regimen; concomitant use of cyclin-dependent kinase (CDK) 4/6 inhibitor(s) is acceptable; Previous chemotherapy is not required, but up to 2 prior regimens of cytotoxic chemotherapy is allowed.
Patients who have adequate organ functions at baseline

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)
Received radiotherapy (including radioactive isotope therapy) within 4 weeks prior to the first dose of AC682
Major surgery (excluding placement of vascular access) within 4 weeks of first dose of AC682
With known metastasis to the brain
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 1001Recruiting
Site 1003
Site 1002

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. The participants will participate in this dose escalation arm.

Outcomes

Primary Outcome Measures

Incidence of dose limiting toxicities (DLTs) from AC682 monotherapy

Number of subjects with DLT

Incidence of treatment emergent adverse events(TEAEs) from AC682 monotherapy

Number of adverse events as characterized by type, frequency, seriousness, and relationship to AC682

Secondary Outcome Measures

To determine the PK of AC682 after a single dose or multiple doses:

Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf))

To determine the PK of AC682 after a single dose or multiple doses:

Area under the concentration-time curve over the dosing interval (AUC(0-tau))

To determine the PK of AC682 after a single dose or multiple doses:

Maximum plasma concentration (Cmax)

To determine the PK of AC682 after a single dose or multiple doses:

Time to maximum plasma concentration (tmax)

To determine the PK of AC682 after a single dose or multiple doses:

Terminal elimination half life (t1/2)

To evaluate the preliminary anti-tumor activity of AC682:

Objective Response Rate(ORR) using RECIST version 1.1

To evaluate the preliminary anti-tumor activity of AC682:

Clinical Benefit Rate (CBR) using RECIST version 1.1

To evaluate the preliminary anti-tumor activity of AC682:

Duration of Response (DoR) using RECIST version 1.1

To evaluate the preliminary anti-tumor activity of AC682:

Disease Control Rate (DCR) using RECIST version 1.1

To evaluate the preliminary anti-tumor activity of AC682:

Progression-free Survival (PFS) using RECIST version 1.1

Full Information

NCT ID

NCT05489679

First Posted

July 15, 2022

Last Updated

October 26, 2022

Sponsor

Accutar Biotechnology Inc

1. Study Identification

Unique Protocol Identification Number

NCT05489679

Brief Title

A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer

Official Title

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

December 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This clinical trial is evaluating 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: To evaluate the safety and tolerability of AC682 To evaluate the pharmacokinetic of AC682 To evaluate the preliminary anti-tumor activity of AC682

Detailed Description

This is a Phase I, 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, AC682, 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

150 (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. The 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) from AC682 monotherapy

Description

Number of subjects with DLT

Time Frame

28 days

Title

Incidence of treatment emergent adverse events(TEAEs) from AC682 monotherapy

Description

Number of adverse events as characterized by type, frequency, seriousness, and relationship to AC682

Time Frame

Throughout the study completion, approximately 24 months

Secondary Outcome Measure Information:

Title

To determine the PK of AC682 after a single dose or multiple doses:

Description

Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf))

Time Frame

At predefined intervals throughout the study completion, approximately 24 months.

Title

To determine the PK of AC682 after a single dose or multiple doses:

Description

Area under the concentration-time curve over the dosing interval (AUC(0-tau))

Time Frame

At predefined intervals throughout the study completion, approximately 24 months.

Title

To determine the PK of AC682 after a single dose or multiple doses:

Description

Maximum plasma concentration (Cmax)

Time Frame

At predefined intervals throughout the study completion, approximately 24 months.

Title

To determine the PK of AC682 after a single dose or multiple doses:

Description

Time to maximum plasma concentration (tmax)

Time Frame

At predefined intervals throughout the study completion, approximately 24 months.

Title

To determine the PK of AC682 after a single dose or multiple doses:

Description

Terminal elimination half life (t1/2)

Time Frame

At predefined intervals throughout the study completion, approximately 24 months.

Title

To evaluate the preliminary anti-tumor activity of AC682:

Description

Objective Response Rate(ORR) using RECIST version 1.1

Time Frame

Throughout the study completion, approximately 24 months

Title

To evaluate the preliminary anti-tumor activity of AC682:

Description

Clinical Benefit Rate (CBR) using RECIST version 1.1

Time Frame

Throughout the study completion, approximately 24 months

Title

To evaluate the preliminary anti-tumor activity of AC682:

Description

Duration of Response (DoR) using RECIST version 1.1

Time Frame

Throughout the study completion, approximately 24 months

Title

To evaluate the preliminary anti-tumor activity of AC682:

Description

Disease Control Rate (DCR) using RECIST version 1.1

Time Frame

Throughout the study completion, approximately 24 months

Title

To evaluate the preliminary anti-tumor activity of AC682:

Description

Progression-free Survival (PFS) using RECIST version 1.1

Time Frame

Throughout the study completion, approximately 24 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be ≥18 years-of-age at the time of signing of the ICF Histologically and/or cytologically confirmed advanced estrogen receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer Female patients must be postmenopausal 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 Previously received at least 1 endocrine therapy regimen; concomitant use of cyclin-dependent kinase (CDK) 4/6 inhibitor(s) is acceptable; Previous chemotherapy is not required, but up to 2 prior regimens of cytotoxic chemotherapy is allowed. Patients who have adequate organ functions at baseline 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) Received radiotherapy (including radioactive isotope therapy) within 4 weeks prior to the first dose of AC682 Major surgery (excluding placement of vascular access) within 4 weeks of first dose of AC682 With known metastasis to the brain 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Accutar Biotechnology

Phone

9292620884

medical@accutarbio.com

Facility Information:

Facility Name

Site 1001

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Name

Site 1003

City

Hangzhou

Country

China

Individual Site Status

Not yet recruiting

Facility Name

Site 1002

City

Tianjin

Country

China

Individual Site Status

Not yet recruiting

12. IPD Sharing Statement

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A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer

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