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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 a drug called 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, first in human, 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. Up to 30 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) | 28 days (Cycle 1) | |
| Incidence of treatment-emergent adverse events (TEAEs), and clinically significant grade 3 or higher laboratory abnormalities following administration of AC682 | Adverse events will be graded according to NCI CTCAE v5.0. | Through study completion, approximately 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) as a measure of anti-tumor activity | Through study completion, approximately 18 months | |
| Clinical benefit rate (CBR) as a measure of anti-tumor activity | Through study completion, approximately 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Denver | Colorado | 80218 | United States | ||
| Site 04 |
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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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| Duration of response (DOR) as a measure of anti-tumor activity | Through study completion, approximately 18 months |
| Disease control rate (DCR) as a measure of anti-tumor activity | Through study completion, approximately 18 months |
| Progression free survival (PFS) as a measure of anti-tumor activity | Through study completion, approximately 18 months |
| Pharmacokinetic Analysis: area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf)) | Through study completion, approximately 18 months |
| Pharmacokinetic Analysis: area under the concentration-time curve over the dosing interval (AUC(0-tau)) | Through study completion, approximately 18 months |
| Pharmacokinetic Analysis: maximum plasma concentration (Cmax) | Through study completion, approximately 18 months |
| Pharmacokinetic Analysis: time to maximum plasma concentration (tmax) | Through study completion, approximately 18 months |
| Pharmacokinetic Analysis: terminal elimination half life (t1/2) | Through study completion, approximately 18 months |
| Orlando |
| Florida |
| 32827 |
| United States |
| Site 02 | Sarasota | Florida | 34232 | United States |
| Site 03 | Nashville | Tennessee | 37203 | United States |
| Site 05 | Houston | Texas | 77030 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |