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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05489679
• Other study ID #: AC682-002
• Status: Terminated
• Phase: Phase 1
• Start date: October 1, 2022
• Est. completion date: September 28, 2023

Study information

• Verified date: January 2024
• Source: Accutar Biotechnology Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This is a Phase I, open-label dose-escalation study of AC682, an orally available estrogen receptor degrader, given as a single agent.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 28, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Site 1001	Beijing
China	Site 1003	Hangzhou
China	Site 1002	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Accutar Biotechnology Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose limiting toxicities (DLTs) from AC682 monotherapy	Number of subjects with DLT	28 days
Primary	Incidence of treatment emergent adverse events(TEAEs) from AC682 monotherapy	Number of adverse events as characterized by type, frequency, seriousness, and relationship to AC682	Throughout the study completion, approximately 24 months
Secondary	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))	At predefined intervals throughout the study completion, approximately 24 months.
Secondary	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))	At predefined intervals throughout the study completion, approximately 24 months.
Secondary	To determine the PK of AC682 after a single dose or multiple doses:	Maximum plasma concentration (Cmax)	At predefined intervals throughout the study completion, approximately 24 months.
Secondary	To determine the PK of AC682 after a single dose or multiple doses:	Time to maximum plasma concentration (tmax)	At predefined intervals throughout the study completion, approximately 24 months.
Secondary	To determine the PK of AC682 after a single dose or multiple doses:	Terminal elimination half life (t1/2)	At predefined intervals throughout the study completion, approximately 24 months.
Secondary	To evaluate the preliminary anti-tumor activity of AC682:	Objective Response Rate(ORR) using RECIST version 1.1	Throughout the study completion, approximately 24 months
Secondary	To evaluate the preliminary anti-tumor activity of AC682:	Clinical Benefit Rate (CBR) using RECIST version 1.1	Throughout the study completion, approximately 24 months
Secondary	To evaluate the preliminary anti-tumor activity of AC682:	Duration of Response (DoR) using RECIST version 1.1	Throughout the study completion, approximately 24 months
Secondary	To evaluate the preliminary anti-tumor activity of AC682:	Disease Control Rate (DCR) using RECIST version 1.1	Throughout the study completion, approximately 24 months
Secondary	To evaluate the preliminary anti-tumor activity of AC682:	Progression-free Survival (PFS) using RECIST version 1.1	Throughout the study completion, approximately 24 months