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

NCT05489679 | Terminated Phase 1

• 1 other identifier: AC682-002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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. 1.To evaluate the safety and tolerability of AC682
2. 2.To evaluate the pharmacokinetic of AC682
3. 3.To evaluate the preliminary anti-tumor activity of AC682

Conditions

Breast Cancer

Keywords

Estrogen receptor positive; ER positive; ER+; Human epidermal growth factor receptor 2 negative; HER2 negative; AC682; Phase I

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicities (DLTs) from AC682 monotherapy

  Number of subjects with DLT

  28 days

• 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 Outcomes (10)

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

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

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

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

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

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

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

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

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

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

Study Arms (1)

AC682

EXPERIMENTAL

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

Drug: AC682

Interventions

AC682 DRUG

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

AC682

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Accutar Biotechnology Inc: lead

Study Sites (3)

Site 1001

Beijing, China

Location

Site 1003

Hangzhou, China

Location

Site 1002

Tianjin, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: August 5, 2022
• Study Start: October 1, 2022
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

CN (3)