Breast Cancer
Conditions
Keywords
Estrogen receptor positive, ER positive, ER+, Human epidermal growth factor receptor 2 negative, HER2 negative, AC682, Phase I
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.
Interventions
DRUGAC682
Participants will receive AC682 by mouth daily in 28-day cycles.
Sponsors
Accutar Biotechnology Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events(TEAEs) from AC682 monotherapy | Throughout the study completion, approximately 24 months | Number of adverse events as characterized by type, frequency, seriousness, and relationship to AC682 |
| Incidence of dose limiting toxicities (DLTs) from AC682 monotherapy | 28 days | Number of subjects with DLT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the PK of AC682 after a single dose or multiple doses: | At predefined intervals throughout the study completion, approximately 24 months. | Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf)) |
| To evaluate the preliminary anti-tumor activity of AC682: | Throughout the study completion, approximately 24 months | Objective Response Rate(ORR) using RECIST version 1.1 |
Countries
China
Outcome results
None listed