Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-27 @ 10:38 PM
Study NCT ID:
NCT05307705
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2022-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077267', 'term': 'Fulvestrant'}, {'id': 'C000719756', 'term': 'Imlunestrant'}, {'id': 'C000590451', 'term': 'abemaciclib'}, {'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'C056516', 'term': 'exemestane'}, {'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2022-03-25', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1 a: To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of LOXO-783: Number of patients with dose-limiting toxicities (DLTs)', 'timeFrame': 'During the first 28-day cycle of LOXO-783 treatment', 'description': 'Number of patients with DLTs'}, {'measure': 'Phase 1 a: To determine the MTD/RP2D of LOXO-783: Number of patients with DLT-equivalent toxicities', 'timeFrame': 'During the first 28-day cycle of LOXO-783 treatment', 'description': 'Number of patients with DLT-equivalent toxicities'}], 'secondaryOutcomes': [{'measure': 'To assess the pharmacokinetics (PK) of LOXO-783: Area under the concentration versus time curve (AUC)', 'timeFrame': 'Up to 2 months', 'description': 'PK of LOXO-783: AUC'}, {'measure': 'To assess the PK of LOXO-783: Maximum drug concentration (Cmax)', 'timeFrame': 'Up to 2 months', 'description': 'PK of LOXO-783: Cmax'}, {'measure': 'To evaluate the preliminary antitumor activity of LOXO-783: Overall response rate (ORR)', 'timeFrame': 'Up to approximately 36 months or 3 years', 'description': 'ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)'}, {'measure': 'To evaluate the preliminary antitumor activity of LOXO-783: Best overall response (BOR)', 'timeFrame': 'Up to approximately 36 months or 3 years', 'description': 'BOR per investigator assessed RECIST 1.1'}, {'measure': 'To evaluate the preliminary antitumor activity of LOXO-783: Duration of response (DOR)', 'timeFrame': 'Up to approximately 36 months or 3 years', 'description': 'DOR per investigator assessed RECIST 1.1'}, {'measure': 'To evaluate the preliminary antitumor activity of LOXO-783: Disease control rate (DCR)', 'timeFrame': 'Up to approximately 36 months or 3 years', 'description': 'DCR per investigator assessed RECIST 1.1'}, {'measure': 'To evaluate the preliminary antitumor activity of LOXO-783: Clinical benefit rate (CBR)', 'timeFrame': 'Up to approximately 36 months or 3 years', 'description': 'CBR per investigator assessed RECIST 1.1'}, {'measure': 'To evaluate the preliminary antitumor activity of LOXO-783: Time to response (TTR)', 'timeFrame': 'Up to approximately 36 months or 3 years', 'description': 'TTR per investigator assessed RECIST 1.1'}, {'measure': 'To evaluate the preliminary antitumor activity of LOXO-783: Progression free survival (PFS)', 'timeFrame': 'Up to approximately 36 months or 3 years', 'description': 'PFS per investigator assessed RECIST 1.1'}, {'measure': 'To evaluate the preliminary antitumor activity of LOXO-783: Overall survival (OS)', 'timeFrame': 'Up to approximately 36 months or 3 years', 'description': 'OS per investigator assessed RECIST 1.1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/338185', 'label': 'A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have advanced breast cancer or another solid tumor with the presence of a phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)\n* Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.\n* Have stopped all cancer treatment and have recovered from the major side effects\n* Have adequate organ function, as measured by blood tests\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale\n* Patients must have\n\n * Measurable disease\n\n \\--- Patients with non-breast tumor types must have at least 1 measurable lesion\n * Non-measurable bone disease (at least 1 bone lesion in breast cancer patients only)\n* For patients with an estrogen receptor (ER)+ breast cancer diagnosis:\n\n * If female, must be postmenopausal\n * If male, must agree to use hormone suppression\n* Phase 1a:\n\n \\-- Dose escalation and backfill patients:\n * Advanced solid tumor\n * Patients may have had up to 5 prior regimens for advanced disease\n* Phase 1b:\n\n * Part A:\n\n * ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer\n * Patients may have had up to 5 prior regimens for advanced disease ---- Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required\n * Part B:\n\n * ER+/HER2- advanced breast cancer\n * Patients may have had up to 2 prior regimens for advanced disease.\n * Part C:\n\n * ER+/HER2- advanced breast cancer\n * Patients may have had up to 5 prior regimens for advanced disease.\n\n \\---- Prior CDK4/6 inhibitor therapy required.\n * Have a diagnosis of diabetes mellitus Type 2\n * Part D:\n\n * Advanced breast cancer\n * Patients may have had up to 5 prior regimens for advanced disease.\n * Part E:\n\n * Advanced solid tumor\n * Patients may have had up to 3 prior regimens for advanced disease advanced disease\n * Part F:\n\n * ER+/HER2- advanced breast cancer\n * Patients may have had up to 5 prior regimens for advanced disease\n\n * Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required\n\nExclusion Criteria:\n\n* Medical Conditions\n\n * Colorectal cancer\n * Endometrial cancers with specific concurrent oncogenic alterations\n * A history of known active or suspected\n\n * Diabetes mellitus Type 1 or\n * Diabetes mellitus Type 2 requiring antidiabetic medication (Phase 1a and all parts of Phase 1b except Part C).\n * Serious concomitant systemic disorder\n* Known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.\n* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process\n* Prior exposure to phosphatidylinositol 3-kinase/protein kinase B/mammalian target of rapamycin (PI3K/AKT/mTOR) inhibitor(s), except in certain circumstances'}, 'identificationModule': {'nctId': 'NCT05307705', 'acronym': 'PIKASSO-01', 'briefTitle': 'A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation', 'orgStudyIdInfo': {'id': '18394'}, 'secondaryIdInfos': [{'id': '2022-000175-40', 'type': 'EUDRACT_NUMBER'}, {'id': 'J4C-OX-JZUA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'LOXO-PIK-21001', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1A: LOXO-783 Monotherapy Dose Escalation', 'description': 'LOXO-783 administered orally', 'interventionNames': ['Drug: LOXO-783']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1B: Part A', 'description': 'LOXO-783 administered orally in combination with fulvestrant intramuscularly, imlunestrant orally, or an aromatase inhibitor orally', 'interventionNames': ['Drug: LOXO-783', 'Drug: Fulvestrant', 'Drug: Imlunestrant', 'Drug: Anastrozole, Exemestane, or Letrozole']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1B: Part B', 'description': "LOXO-783 orally in combination with abemaciclib and either physician's choice aromatase inhibitor orally, fulvestrant intramuscularly, or imlunestrant orally", 'interventionNames': ['Drug: LOXO-783', 'Drug: Fulvestrant', 'Drug: Imlunestrant', 'Drug: Abemaciclib', 'Drug: Anastrozole, Exemestane, or Letrozole']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1B: Part C', 'description': 'LOXO-783 orally in combination with fulvestrant intramuscularly', 'interventionNames': ['Drug: LOXO-783', 'Drug: Fulvestrant']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1B: Part D', 'description': 'LOXO-783 orally in combination with paclitaxel intravenously', 'interventionNames': ['Drug: LOXO-783', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1B: Part E', 'description': 'LOXO-783 orally', 'interventionNames': ['Drug: LOXO-783']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1B: Part F', 'description': 'Multiple randomized dose levels of LOXO-783 orally with fulvestrant intramuscularly', 'interventionNames': ['Drug: LOXO-783', 'Drug: Fulvestrant']}], 'interventions': [{'name': 'LOXO-783', 'type': 'DRUG', 'otherNames': ['LY3849524'], 'description': 'Oral', 'armGroupLabels': ['Phase 1A: LOXO-783 Monotherapy Dose Escalation', 'Phase 1B: Part A', 'Phase 1B: Part B', 'Phase 1B: Part C', 'Phase 1B: Part D', 'Phase 1B: Part E', 'Phase 1B: Part F']}, {'name': 'Fulvestrant', 'type': 'DRUG', 'description': 'Intramuscular', 'armGroupLabels': ['Phase 1B: Part A', 'Phase 1B: Part B', 'Phase 1B: Part C', 'Phase 1B: Part F']}, {'name': 'Imlunestrant', 'type': 'DRUG', 'otherNames': ['LY3484356'], 'description': 'Oral', 'armGroupLabels': ['Phase 1B: Part A', 'Phase 1B: Part B']}, {'name': 'Abemaciclib', 'type': 'DRUG', 'otherNames': ['LY2835219'], 'description': 'Oral', 'armGroupLabels': ['Phase 1B: Part B']}, {'name': 'Anastrozole, Exemestane, or Letrozole', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['Phase 1B: Part A', 'Phase 1B: Part B']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Intravenous', 'armGroupLabels': ['Phase 1B: Part D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic of Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center at Mission Bay', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Hospital', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Center Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905-0002', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University Medical School', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Wilmot Cancer Institute', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology PLLC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Baylor Charles A. 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Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}