Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-01-01 @ 11:41 PM
Study NCT ID:
NCT07038369
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077267', 'term': 'Fulvestrant'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expansion: Maximum and minimum plasma concentration', 'timeFrame': 'Approximately 48 months.', 'description': 'Drug concentration in Blood.'}, {'measure': 'Expansion: Time to C Max', 'timeFrame': 'Approximately 48 months', 'description': 'Drug concentration in Blood'}, {'measure': 'Expansion: Area under the concentration-time curve', 'timeFrame': 'Approximately 48 months', 'description': 'Drug concentration in Blood'}, {'measure': 'Expansion: AUC at end of dosing interval', 'timeFrame': 'Approximately 48 months', 'description': 'Drug concentration in Blood'}, {'measure': 'Expansion: AUC extrapolated to infinity', 'timeFrame': 'Approximately 48 months', 'description': 'Drug concentration in Blood'}, {'measure': 'Expansion: Half-life', 'timeFrame': 'Approximately 48 months', 'description': 'Drug concentration in Blood'}, {'measure': 'Expansion: Trough Concentrations', 'timeFrame': 'Approximately 48 months', 'description': 'Drug concentration in Blood'}, {'measure': 'Escalation & Expansion: Safety and Tolerability of monotherapy.', 'timeFrame': 'Approximately 48 months.', 'description': 'Number of participants with Treatment Emergent Adverse Events (TEAEs). Safety will be assessed by monitoring adverse events, laboratory tests and ECG results.'}, {'measure': 'Escalation: Maximum tolerated dose and/or recommended phase 2 dose of ATV-1601 in monotherapy.', 'timeFrame': 'Approximately 48 months.', 'description': 'Number of patients with dose-limiting toxicities.'}, {'measure': 'Escalation: Maximum tolerated dose and/or recommended phase 2 dose of ATV-1601 combination with fulvestrant.', 'timeFrame': 'Approximately 48 months.', 'description': 'Number of patients with dose-limiting toxicities.'}], 'secondaryOutcomes': [{'measure': 'Escalation: Maximum and minimum plasma concentration', 'timeFrame': 'Approximately 48 months.', 'description': 'Drug concentration in Blood.'}, {'measure': 'Escalation: Time to C max', 'timeFrame': 'Approximately 48 months', 'description': 'Drug concentration in Blood'}, {'measure': 'Escalation: Area under the concentration-time curve', 'timeFrame': 'Approximately 48 months', 'description': 'Drug concentration in Blood'}, {'measure': 'Escalation: AUC at end of dosing interval', 'timeFrame': 'Approximately 48 months', 'description': 'Drug concentration in Blood'}, {'measure': 'Escalation: AUC extrapolated to infinity', 'timeFrame': 'Approximately 48 months', 'description': 'Drug concentration in Blood'}, {'measure': 'Escalation: Half-life', 'timeFrame': 'Approximately 48 months', 'description': 'Drug concentration in Blood'}, {'measure': 'Escalation: Trough Concentrations', 'timeFrame': 'Approximately 48 months', 'description': 'Drug concentration in Blood'}, {'measure': 'Escalation & Expansion: Objective response rate', 'timeFrame': 'Approximately 48 months', 'description': 'Tumor measurements by RECIST 1.1'}, {'measure': 'Escalation & Expansion: Duration of Response', 'timeFrame': 'Approximately 48 months', 'description': 'Tumor measurements by RECIST 1.1'}, {'measure': 'Escalation & Expansion: Clinical Benefit Rate', 'timeFrame': 'Approximately 48 months', 'description': 'Tumor measurements by RECIST 1.1'}, {'measure': 'Expansion: Progression Free Survival', 'timeFrame': 'Approximately 48 months', 'description': 'Tumor measurements by RECIST 1.1'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AKT mutation', 'Mutant AKT', 'AKT1 mutation', 'AKT mutant', 'Gynecologic carcinoma', 'Fallopian Carcinoma', 'Fallopian Neoplasm', 'HR positive breast', 'AKT Gene Mutation', 'AKT1 E17K'], 'conditions': ['Advanced Solid Tumors', 'Breast Cancer', 'Breast Carcinoma', 'Breast Neoplasms', 'ER Positive Breast Cancer', 'Cervical Cancers', 'Cervical Neoplasms', 'Cervical Carcinoma', 'Triple Negative Breast Cancer', 'Gynecologic Cancers', 'Gynecologic Neoplasm', 'Endometrial Cancer', 'Endometrial Neoplasm', 'Endometrial Carcinoma (EC)', 'Fallopian Cancer', 'Ovarian Carcinoma', 'Ovarian Cancer', 'Ovarian Neoplasms', 'Prostate Cancers', 'Prostate Carcinoma', 'Solid Tumors', 'Neoplasms', 'Neoplasms by Site', 'Breast Diseases', 'Uterine Neoplasms', 'Genital Neoplasms, Female', 'Urogenital Neoplasms']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, open-label study to evaluate the safety and tolerability of ATV-1601 administered orally in adults with AKT1 E17K-mutant, advanced solid tumors and also in HR+/HER2- advanced and metastatic breast cancer, with or without fulvestrant.', 'detailedDescription': 'This is a first-in-human, open-label, multicenter, Phase 1a/1b dose escalation dose finding, and dose expansion study to evaluate safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of ATV-1601 as monotherapy in participants with advanced or metastatic solid tumors with the AKT1 E17K mutation, and in combination with fulvestrant in participants with breast cancer that has the AKT1 E17K mutation. This study has a dose escalation and expansion phase with ATV-1601, and an escalation and expansion phase in combination with Fulvestrant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed metastatic or advanced-stage solid malignant tumor or HR+/HER2- breast cancer.\n2. Have progressed on, were intolerant to, or experienced disease recurrence after standard therapy and have no available effective or tolerable treatment options to derive clinically meaningful benefit.\n3. Tumor must have documented specific mutation profile as outlined below based on local laboratory testing.\n4. Participants with solid tumors or HR+/HER2- breast cancer with AKT1 E17K mutations.\n5. Measurable disease according to RECIST v1.1 criteria.\n6. Formalin-fixed paraffin-embedded tumor specimen available for submission.\n7. Eastern Cooperative Oncology Group performance status of 0 or 1.\n\nExclusion Criteria:\n\n1. Previously documented activating mutations in KRAS, NRAS, HRAS, or BRAF.\n2. Inadequate bone marrow reserve or organ function.\n3. Clinically significant abnormalities of glucose metabolism.\n4. Participants who are symptomatic or have uncontrolled brain metastases.\n5. Requires treatment with certain medications.\n\nParticipants must meet other inclusion/exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT07038369', 'briefTitle': 'A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atavistik Bio, Inc'}, 'officialTitle': 'A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'ATV-1601-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental/Part 1a: ATV-1601', 'description': 'ATV-1601', 'interventionNames': ['Drug: ATV-1601']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental/Part 1b: ATV-1601 + Fulvestrant', 'description': 'ATV-1601 + Fulvestrant', 'interventionNames': ['Combination Product: ATV-1601 + Fulvestrant']}], 'interventions': [{'name': 'ATV-1601', 'type': 'DRUG', 'description': 'Drug: ATV-1601\n\n• Oral ATV-1601', 'armGroupLabels': ['Experimental/Part 1a: ATV-1601']}, {'name': 'ATV-1601 + Fulvestrant', 'type': 'COMBINATION_PRODUCT', 'description': 'Drug: ATV-1601\n\n* Oral ATV-1601 Drug: Fulvestrant\n* Intramuscular Injection', 'armGroupLabels': ['Experimental/Part 1b: ATV-1601 + Fulvestrant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Studydirector@atavitikbio.com', 'phone': '857-285-5400', 'phoneExt': '101'}], 'facility': 'USC Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32746', 'city': 'Lake Mary', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Studydirector@atavistikbio.com', 'phone': '857-285-5400', 'phoneExt': '101'}], 'facility': 'Florida Cancer Specialists & Research Institute - Lake Mary', 'geoPoint': {'lat': 28.75888, 'lon': -81.31784}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Studydirector@atavistikbio.com', 'phone': '857-285-5400', 'phoneExt': '101'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Studydirector@atavitikbio.com', 'phone': '857-285-5400', 'phoneExt': '101'}], 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Studydirector@atavistikbio.com', 'phone': '857-285-5400', 'phoneExt': '101'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Studydirector@atavistikbio.com', 'phone': '857-285-5400', 'phoneExt': '101'}], 'facility': 'The Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Studydirector@atavistikbio.com', 'phone': '857-285-5400', 'phoneExt': '101'}], 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Studydirector@atavistikbio.com', 'phone': '857-285-5400', 'phoneExt': '101'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '69008', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Studydirector@atavistikbio.com', 'phone': '857-285-5400', 'phoneExt': '101'}], 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '168583', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Studydirector@atavistikbio.com', 'phone': '857-285-5400', 'phoneExt': '101'}], 'facility': 'National Cancer Centre Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Studydirector@atavistikbio.com', 'phone': '857-285-5400', 'phoneExt': '101'}], 'facility': 'Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Studydirector@atavistikbio.com', 'phone': '857-285-5400', 'phoneExt': '101'}], 'facility': 'START Madrid - Hospital Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Studydirector@atavistikbio.com', 'phone': '857-285-5400', 'phoneExt': '101'}], 'facility': 'START Madrid - CIOCC', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'Studydirector@atavistikbio.com', 'phone': '+1- 857-285-5400', 'phoneExt': '101'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Atavistik Bio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atavistik Bio, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}