Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT06736704
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2024-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SNV4818 in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2024-12-12', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose limiting toxicities (DLTs)', 'timeFrame': 'First 28 days of study treatment', 'description': '-Number of participants experiencing protocol-defined DLTs (Part 1A and 2A only)'}, {'measure': 'Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first SNV4818 dose through approximately 30 days following the last SNV4818 dose', 'description': 'Incidence and frequency of TEAEs'}], 'secondaryOutcomes': [{'measure': 'Maximum observed plasma concentration of SNV4818', 'timeFrame': 'After 4 weeks (1 cycle) of study treatment', 'description': 'Cmax'}, {'measure': 'Time to reach the maximum observed plasma concentration of SNV4818', 'timeFrame': 'After 4 weeks (1 cycle) of study treatment', 'description': 'Tmax'}, {'measure': 'Area Under Plasma Concentration (AUC) Time Curve of SNV4818', 'timeFrame': 'After 4 weeks (1 cycle) of study treatment', 'description': 'AUC0-t'}, {'measure': 'Half-life of SNV4818', 'timeFrame': 'After 4 weeks (1 cycle) of study treatment', 'description': 't1/2'}, {'measure': 'Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity', 'timeFrame': 'After 1 day of study treatment', 'description': 'AUC0-infinity'}, {'measure': 'Apparent oral clearance of SNV4818', 'timeFrame': 'After 4 weeks (1 cycle) of study treatment', 'description': 'CL/F'}, {'measure': 'Apparent volume of distribution of SNV4818', 'timeFrame': 'After 4 weeks (1 cycle) of study treatment', 'description': 'Vz/F'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'After 8 weeks on study treatment', 'description': 'The proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR), based on RECIST 1.1 criteria'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'After 8 weeks on study treatment', 'description': 'The proportion of participants who have a best overall response (BOR) of stable disease (SD) or better'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'The time interval between an assessment of partial response (PR) or better and disease progression or death due to any cause.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This study is testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the safest and most effective one.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced or metastatic solid tumor with an activating PIK3CA mutation.\n* Refractory to or intolerant of available therapies\n* Disease measurable by RECIST 1.1 criteria, or disease evaluable by clinically relevant tumor biomarkers in blood.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\n* Diagnosis of a primary CNS malignancy\n* Active brain metastases or carcinomatous meningitis\n* Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus\n* Inadequate organ function\n* Clinically significant ECG abnormalities, including QTcF ≥ 470 ms'}, 'identificationModule': {'nctId': 'NCT06736704', 'briefTitle': 'SNV4818 in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pikavation Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV4818 as Monotherapy or in Combination With Other Anticancer Agents in Participants With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'SNV4818-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SNV4818 Monotherapy', 'description': 'Participants will receive oral, daily doses of SNV4818 as a single agent as part of either dose escalation or dose expansion cohorts. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation.', 'interventionNames': ['Drug: SNV4818']}, {'type': 'EXPERIMENTAL', 'label': 'SNV4818+Fulvestrant Combination', 'description': 'Participants will receive oral, daily doses of SNV4818 in combination with a standard dose of Fulvestrant as part of either dose escalation or dose expansion cohorts.. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation.', 'interventionNames': ['Drug: SNV4818', 'Drug: Fulvestrant']}], 'interventions': [{'name': 'SNV4818', 'type': 'DRUG', 'description': 'SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.', 'armGroupLabels': ['SNV4818 Monotherapy', 'SNV4818+Fulvestrant Combination']}, {'name': 'Fulvestrant', 'type': 'DRUG', 'otherNames': ['Faslodex'], 'description': 'Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)', 'armGroupLabels': ['SNV4818+Fulvestrant Combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Thomas Jefferson University-Sidney Kimmel Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The University of Texas M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': "Chris O'Brien Lifehouse", 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Scientia Clinical Research', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Monash Health', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Linear Clinical Research', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'The Ottawa Hospital Cancer Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'University Health Network, Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Robert Casper', 'role': 'CONTACT', 'email': 'rcasper@synnovationtx.com', 'phone': '443-764-9527'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pikavation Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}