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

NCT ID: NCT05489679

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-09-28

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:

1. To evaluate the safety and tolerability of AC682

2. To evaluate the pharmacokinetic of AC682

3. 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AC682

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

Group Type: EXPERIMENTAL

AC682

Intervention Type: DRUG

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

Interventions

AC682

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients must be ≥18 years-of-age at the time of signing of the ICF

2. Histologically and/or cytologically confirmed advanced estrogen receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer

3. Female patients must be postmenopausal

4. 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

5. 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.

6. Patients who have adequate organ functions at baseline

Exclusion Criteria

1. 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)

2. Received radiotherapy (including radioactive isotope therapy) within 4 weeks prior to the first dose of AC682

3. Major surgery (excluding placement of vascular access) within 4 weeks of first dose of AC682

4. With known metastasis to the brain

5. 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.

6. Use of prophylactic growth factors and blood transfusions ≤14 days prior to the first dose of AC682 and during dose limiting toxicity observation period

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Accutar Biotechnology Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Site 1001

Beijing, , China

Site 1003

Hangzhou, , China

Site 1002

Tianjin, , China

Countries

China

Other Identifiers

AC682-002

Identifier Type: -

Identifier Source: org_study_id