Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-02-18 @ 2:10 PM
Study NCT ID:
NCT05654532
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2022-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2022-12-08', 'studyFirstSubmitQcDate': '2022-12-08', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose limiting toxicities (DLTs) from AC699 monotherapy', 'timeFrame': 'First 28 days of treatment. Cycles are 28 days.'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs) and clinically significant Grade 3 or higher lab abnormalities following administration of AC699', 'timeFrame': 'Approximately 18 months.'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR) to assess the anti-tumor activity of AC699', 'timeFrame': 'Approximately 18 months.'}, {'measure': 'Clinical Benefit Rate (CBR) to assess the anti-tumor activity of AC699 using RECIST 1.1', 'timeFrame': 'Approximately 18 months.'}, {'measure': 'Duration of Response (DOR) to assess the anti-tumor activity of AC699 using RECIST 1.1', 'timeFrame': 'Approximately 18 months.'}, {'measure': 'Disease Control Rate (DCR) to assess the anti-tumor activity of AC699 using RECIST 1.1', 'timeFrame': 'Approximately 18 months.'}, {'measure': 'Progression Free Survival (PFS) to assess the anti-tumor activity of AC699 using RECIST 1.1', 'timeFrame': 'Approximately 18 months.'}, {'measure': 'Pharmacokinetic Analysis: Area under the concentration-time curve over the dosing interval (AUC(0-infinity))', 'timeFrame': 'Up to approximately 28 weeks'}, {'measure': 'Pharmacokinetic Analysis: Area under the concentration-time curve over the dosing interval (AUC(0-tau))', 'timeFrame': 'Up to approximately 28 weeks'}, {'measure': 'Pharmacokinetic Analysis: Maximum plasma concentration (Cmax)', 'timeFrame': 'Up to approximately 28 weeks'}, {'measure': 'Pharmacokinetic Analysis: Time to maximum plasma concentration (tmax)', 'timeFrame': 'Up to approximately 28 weeks'}, {'measure': 'Pharmacokinetic Analysis: Terminal elimination half-life (t1/2)', 'timeFrame': 'Up to approximately 28 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Estrogen receptor-positive breast cancer', 'ER positive', 'ER+', 'Human epidermal growth factor receptor 2 negative', 'HER2 negative breast cancer', 'HER2-', 'AC699', 'Metastatic breast cancer', 'MBC', 'Locally advanced breast cancer', 'ER chimeric degrader', 'ER degrader'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '41407710', 'type': 'DERIVED', 'citation': 'Hamilton E, Layman RM, Cosgrove D, Danso M, Zhang H, He W, Kim SY, Fan J, Patel MR. ER degradation for ER+/HER2- advanced or metastatic breast cancer: a phase 1 trial. Nat Commun. 2025 Dec 17. doi: 10.1038/s41467-025-67485-y. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial is evaluating a drug called AC699 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:\n\n* Identify the recommended dose of AC699 that can be given safely to participants\n* Evaluate the safety profile of AC699\n* Evaluate the pharmacokinetics of AC699\n* Evaluate the effectiveness of AC699', 'detailedDescription': 'This study is a Phase I, first-in-human, open-label dose-escalation study of AC699, an orally bioavailable estrogen receptor degrader, given as a single agent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed written informed consent (ICF)\n* Adult male and female participants, at least 18 years-of-age at the time of signature of the ICF\n* Female participants must be postmenopausal\n* Confirmed diagnosis of advanced, unresectable, and/or metastatic breast cancer following disease progression on standard treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to standard therapies\n* Histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer\n* Must have received at least 2 prior endocrine or at least 1 prior line of endocrine therapy if combined with CDK4/6 inhibitor\n* Prior chemotherapy is not required, but up to 3 prior regimens of cytotoxic chemotherapy will be allowed in the locally advanced/ metastatic setting\n* At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Appendix B) or at least 1 predominantly lytic bone lesion in the absence of measurable disease\n* Acceptable organ and hematologic function at baseline\n* Life expectancy ≥12 weeks after the start of the treatment\n\nExclusion Criteria:\n\n* Treatment with any of the following:\n\n * Any cytotoxic chemotherapy, investigational agents or other anti-cancer drugs for the treatment of locally advanced or metastatic breast cancer within 14 days prior to the first administration of AC699\n * Radiation therapy within 14 days prior to first study drug administration that did not resolve to tolerable toxicity, or prior irradiation to \\>25% of bone marrow. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed 7 days prior to study enrollment and no clinically significant toxicities are expected (e.g., mucositis, esophagitis).\n * Major surgery within 21 days prior to the first study drug administration (exception: participants may enroll if fully recovered or without intolerable or clinically significant adverse effects but at least 14 days must have elapsed between major surgery and first study drug administration)\n* Known symptomatic brain metastases requiring the use of systemic corticosteroids ≥10 mg/day prednisone or equivalents. Asymptomatic and treated, or asymptomatic untreated brain metastases are allowed as long as participants are clinically stable. Stable doses of anticonvulsants are allowed.\n* Any condition that impairs a participant'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 AC699."}, 'identificationModule': {'nctId': 'NCT05654532', 'briefTitle': 'Study of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Accutar Biotechnology Inc'}, 'officialTitle': 'A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'AC699-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AC699 Dose Escalation', 'description': 'Participants will receive an assigned dose of AC699 monotherapy during dose escalation.\n\nOne cycle is defined as 28 days.', 'interventionNames': ['Drug: AC699']}], 'interventions': [{'name': 'AC699', 'type': 'DRUG', 'description': 'Participants will receive AC699 orally daily in 28-day cycles.', 'armGroupLabels': ['AC699 Dose Escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Site 08', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32746', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 07', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 02', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '21044', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Site 06', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Site 01', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 03', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 09', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Site 05', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98684', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'Site 04', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Accutar Biotechnology Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}