A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer (NCT05489679) | Clinical Trial Compass
TerminatedPhase 1
A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
Stopped: Voluntarily terminate the study since the sponsor's development strategy was adjusted.
China6 participantsStarted 2022-10-01
Plain-language 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
Who can participate
Age range18 Years
SexFEMALE
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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:
✕. Received radiotherapy (including radioactive isotope therapy) within 4 weeks prior to the first dose of AC682
What they're measuring
1
Incidence of dose limiting toxicities (DLTs) from AC682 monotherapy
Timeframe: 28 days
2
Incidence of treatment emergent adverse events(TEAEs) from AC682 monotherapy
Timeframe: Throughout the study completion, approximately 24 months
. 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