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Voluntarily terminate the study since the sponsor's development strategy was adjusted.
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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:
This is a Phase I, open-label dose-escalation study of AC682, an orally available estrogen receptor degrader, given as a single agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC682 | Experimental | This arm will evaluate AC682 monotherapy administered in 28-day cycles. The participants will participate in this dose escalation arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC682 | Drug | Participants will receive AC682 by mouth daily in 28-day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| To determine the PK of AC682 after a single dose or multiple doses: |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1001 | Beijing | China | ||||
| Site 1003 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Area under the concentration-time curve over the dosing interval (AUC(0-tau)) |
| At predefined intervals throughout the study completion, approximately 24 months. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Hangzhou |
| China |
| Site 1002 | Tianjin | China |
| D017437 |
| Skin and Connective Tissue Diseases |