Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-29 @ 12:06 PM
Study NCT ID:
NCT05765734
Status:
TERMINATED
Last Update Posted:
2025-07-01
First Post:
2023-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of TAS3351 in NSCLC Patients With EGFRmt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Strategic decision, not based on safety concerns', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2023-02-08', 'studyFirstSubmitQcDate': '2023-03-08', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351', 'timeFrame': 'baseline through cycle 1(each cycle is 21 days)', 'description': 'Adverse Events'}, {'measure': 'Dose Escalation: To investigate the safety and determine the recommended Phase 2 dose and dosing schedule of TAS3351', 'timeFrame': 'baseline through cycle 1(each cycle is 21 days)', 'description': 'Incidence of dose limiting toxicities (DLTs)'}, {'measure': 'Dose Expansion: To explore the efficacy of TAS3351', 'timeFrame': 'estimated 9 months', 'description': 'Objective Response Rate (ORR)'}, {'measure': 'Phase 2: To assess the efficacy of TAS3351', 'timeFrame': 'estimated 3 years', 'description': 'Objective Response Rate (ORR)'}], 'secondaryOutcomes': [{'measure': 'Dose Escalation:To evaluate the antitumor activity of TAS3351', 'timeFrame': 'estimated 20 months', 'description': 'Objective response rate (ORR)'}, {'measure': 'Dose Escalation:To evaluate the antitumor activity of TAS3351', 'timeFrame': 'estimated 20 months', 'description': 'Duration of response (DoR)'}, {'measure': 'Dose Escalation:To evaluate the antitumor activity of TAS3351', 'timeFrame': 'estimated 20 months', 'description': 'Disease control rate (DCR)'}, {'measure': 'Dose Escalation: To evaluate the antitumor activity of TAS3351', 'timeFrame': 'estimated 20 months', 'description': 'Progression free survival (PFS)'}, {'measure': 'Dose Escalation: To evaluate the antitumor activity of TAS3351', 'timeFrame': 'estimated 20 months', 'description': 'Overall Survival (OS)'}, {'measure': 'Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351', 'timeFrame': 'Cycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)', 'description': 'Evaluate the maximum plasma concentration (Cmax)'}, {'measure': 'Dose Escalation: To characterize the pharmacokinetics (PK) of TAS3351', 'timeFrame': 'ECycle 1 Day 1 through cycle 1 Day 15 (21-Day cycle)', 'description': 'Area under the plasma concentration-time curve (AUC)'}, {'measure': 'Dose Expansion: To confirm the safety and tolerability of TAS3351 at the recommended phase 2 dose and dosing schedule', 'timeFrame': 'estimated 9 months', 'description': 'Adverse Events (AEs)'}, {'measure': 'Dose Expansion: To further explore the anti-tumor efficacy of TAS3351', 'timeFrame': 'estimated 9 months', 'description': 'Duration of response (DoR) by ICR'}, {'measure': 'Dose Expansion: To further explore the anti-tumor efficacy of TAS3351', 'timeFrame': 'estimated 9 months', 'description': 'Progression Free Survival (PFS) by ICR'}, {'measure': 'Dose Expansion: To further explore the anti-tumor efficacy of TAS3351', 'timeFrame': 'estimated 9 months', 'description': 'Disease Control Rate (DCR) by ICR'}, {'measure': 'Dose Expansion: To further explore the anti-tumor efficacy of TAS3351', 'timeFrame': 'estimated 9 months', 'description': 'Objective Response Rate (ORR) by Investigator Assessment'}, {'measure': 'Dose Expansion: To further explore the anti-tumor efficacy of TAS3351', 'timeFrame': 'estimated 9 months', 'description': 'Duration of Response (DoR) by Investigator Assessment'}, {'measure': 'Dose Expansion: To further explore the anti-tumor efficacy of TAS3351', 'timeFrame': 'estimated 9 months', 'description': 'Progression Free Survival (PFS) by Investigator Assessment'}, {'measure': 'Dose Expansion: To further explore the anti-tumor efficacy of TAS3351', 'timeFrame': 'estimated 9 months', 'description': 'Disease Control Rate (DCR) by Investigator Assessment'}, {'measure': 'Dose Expansion: To further explore the anti-tumor efficacy of TAS3351', 'timeFrame': 'estimated 9 months', 'description': 'Intracranial Objective Response Rate (icORR)'}, {'measure': 'Dose Expansion: To further explore the anti-tumor efficacy of TAS3351', 'timeFrame': 'estimated 9 months', 'description': 'Intracranial Duration of Response (icDOR)'}, {'measure': 'Dose Expansion: To further explore the anti-tumor efficacy of TAS3351', 'timeFrame': 'estimated 9 months', 'description': 'Overall survival (OS)'}, {'measure': 'Phase 2: To evaluate the safety and tolerability of TAS3351', 'timeFrame': 'estimated 3 years', 'description': 'Adverse Events (AEs)'}, {'measure': 'Phase 2: To further assess the efficacy of TAS3351', 'timeFrame': 'estimated 3 years', 'description': 'Duration of response (DoR) by ICR'}, {'measure': 'Phase 2: To further assess the efficacy of TAS3351', 'timeFrame': 'estimated 3 years', 'description': 'Progression Free Survival (PFS) by ICR'}, {'measure': 'Phase 2: To further assess the efficacy of TAS3351', 'timeFrame': 'estimated 3 years', 'description': 'Disease Control Rate (DCR) by ICR'}, {'measure': 'Phase 2: To further assess the efficacy of TAS3351', 'timeFrame': 'estimated 3 years', 'description': 'Objective Response Rate (ORR) by Investigator Assessment'}, {'measure': 'Phase 2: To further assess the efficacy of TAS3351', 'timeFrame': 'estimated 3 years', 'description': 'Duration of Response (DoR) by Investigator Assessment'}, {'measure': 'Phase 2: To further assess the efficacy of TAS3351', 'timeFrame': 'estimated 3 years', 'description': 'Progression Free Survival (PFS) by Investigator Assessment'}, {'measure': 'Phase 2: To further assess the efficacy of TAS3351', 'timeFrame': 'estimated 3 years', 'description': 'Disease Control Rate (DCR) by Investigator Assessment'}, {'measure': 'Phase 2: To further assess the efficacy of TAS3351', 'timeFrame': 'estimated 3 years', 'description': 'Intracranial Objective Response Rate (icORR)'}, {'measure': 'Phase 2: To further assess the efficacy of TAS3351', 'timeFrame': 'estimated 3 years', 'description': 'Intracranial Duration of Response (icDOR)'}, {'measure': 'Phase 2: To further assess the efficacy of TAS3351', 'timeFrame': 'estimated 3 years', 'description': 'Overall survival (OS)'}, {'measure': 'Phase 2:To evaluate patient reported outcomes (PROs)', 'timeFrame': 'estimated 3 years', 'description': 'responses to patient questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Small Cell Lung Cancer', 'NSCLC', 'EGFR mutation', 'C797S mutation', 'TAS3351'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a first-in-human, open label, Phase 1/2 study to investigate the safety and efficacy of TAS3351 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.', 'detailedDescription': 'This study will be conducted in 3 parts (i.e. dose escalation, dose expansion, and a phase 2 portion). The dose escalation part will investigate the safety and determine the recommended phase 2 dose and the recommended dosing regimen of TAS3351 administered orally. The dose expansion part will explore the efficacy of TAS3351 in NSCLC patients with C797S EGFR mutations. The phase 2 part will assess the efficacy of TAS3351 in NSCLC patients with C797S EGFR mutations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Locally advanced, non-resectable or metastatic NSCLC\n* Have adequate organ function\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale\n* Has tumor tissue available to allow for analysis of EGFRmt status\n\nDose Escalation:\n\n• Has any EGFRmt status\n\nDose Escalation back-fill part, Dose Expansion and Phase II:\n\n* Has any sensitizing EGFRmt and a confirmed C797S EGFRmt\n* Has measurable disease per RECIST v1.1\n\nExclusion Criteria:\n\n* Participating in medical research not compatible with this study\n* Symptomatic and unstable CNS metastases\n* Have not recovered from prior cancer treatment\n* Have a significant cardiac condition\n* Are a pregnant or breastfeeding female\n* A serious illness or medical condition\n* Unable to swallow or digest pills'}, 'identificationModule': {'nctId': 'NCT05765734', 'acronym': 'TAS3351', 'briefTitle': 'A Study of TAS3351 in NSCLC Patients With EGFRmt', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiho Oncology, Inc.'}, 'officialTitle': 'A Phase 1/2 Study of TAS3351 in Patients With Advanced Non-Small Cell Lung Cancer and EGFR Mutations', 'orgStudyIdInfo': {'id': '10073010'}, 'secondaryIdInfos': [{'id': '2022-502595-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAS3351 Part A (Dose Escalation)', 'description': 'Dose escalation will assess the safety and determine the recommended phase 2 dose and regimen of TAS3351 administered orally.', 'interventionNames': ['Drug: TAS3351 oral administration']}, {'type': 'EXPERIMENTAL', 'label': 'TAS3351 Part B (Dose Expansion)', 'description': 'TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose determined in Part A.', 'interventionNames': ['Drug: TAS3351 oral administration']}, {'type': 'EXPERIMENTAL', 'label': 'TAS3351 Part C (Phase 2)', 'description': 'To assess efficacy of TAS3351 in NSCLC patients with C797S EGFRmt. TAS3351 will be administered at the recommended phase 2 dose.', 'interventionNames': ['Drug: TAS3351 oral administration']}], 'interventions': [{'name': 'TAS3351 oral administration', 'type': 'DRUG', 'description': 'TAS3351 will be administered orally', 'armGroupLabels': ['TAS3351 Part A (Dose Escalation)', 'TAS3351 Part B (Dose Expansion)', 'TAS3351 Part C (Phase 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University - Lombardi Comprehensive Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas M. D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Next Oncology - Virginia', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '94805', 'city': 'Villejuif', 'state': 'Val De Marne', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Universitaetsklinikum Koeln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'IEO Istituto Europeo di Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '277-8577', 'city': 'Kashiwa-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East'}, {'zip': '411-8777', 'city': 'Sunto-gun', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Shizuoka Cancer Center'}, {'zip': '135-8550', 'city': 'Kōtoku', 'country': 'Japan', 'facility': 'Cancer Institute Hospital of JFCR', 'geoPoint': {'lat': 42.50417, 'lon': 143.14297}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Antoni van Leeuwenhoek', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2333ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center (LUMC)', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '5505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '8035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28401', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'The Christie Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiho Oncology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}