Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
Study NCT ID:
NCT06816992
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-02-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ORIC-114 in Combination with Subcutaneous Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718215', 'term': 'amivantamab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Interval 3+3 dose escalation design followed by dose expansion'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recommended Phase 2 Dose (RP2D)', 'timeFrame': '12 months', 'description': 'RP2D of ORIC-114 in combination with amivantamab by interval 3+3 dose escalation design'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': '12 months', 'description': 'Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1'}, {'measure': 'Duration of response (DOR)', 'timeFrame': '12 months', 'description': 'Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '12 months', 'description': 'Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1'}], 'secondaryOutcomes': [{'measure': 'Plasma PK parameters', 'timeFrame': '28 Days', 'description': 'Peak Plasma Concentration (Cmax)'}, {'measure': 'Plasma PK parameters', 'timeFrame': '28 Days', 'description': 'Time of maximal plasma concentration (Tmax)'}, {'measure': 'Plasma PK parameters', 'timeFrame': '28 Days', 'description': 'Area under the plasma concentration vs time curve (AUC)'}, {'measure': 'Plasma PK parameters', 'timeFrame': '28 Days', 'description': 'Apparent plasma terminal elimination half-life (t1/2)'}, {'measure': 'BICR-Objective response rate (ORR)', 'timeFrame': '12 months', 'description': 'Blinded independent central review (BICR) according to RECIST 1.1 and RANO-BM'}, {'measure': 'BICR-Duration of response (DOR)', 'timeFrame': '12 months', 'description': 'Blinded independent central review (BICR) according to RECIST 1.1 and RANO-BM'}, {'measure': 'BICR-Progression-free survival (PFS)', 'timeFrame': '12 months', 'description': 'Blinded independent central review (BICR) according to RECIST 1.1 and RANO-BM'}, {'measure': 'Intracranial Objective response rate (ORR)', 'timeFrame': '12 months', 'description': 'Blinded independent central review (BICR) according to RECIST 1.1 and RANO-BM'}, {'measure': 'Intracranial Progression-free survival (PFS)', 'timeFrame': '12 months', 'description': 'Blinded independent central review (BICR) according to RECIST 1.1 and RANO-BM'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSCLC', 'EGFR mutations', 'EGFR exon20', 'EGFR exon 20 insertion mutations', 'ORIC-114', 'Amivantamab'], 'conditions': ['Solid Tumors', 'EGFR Exon 20 Insertion Mutations', 'NSCLC', 'EGFR-mutated NSCLC']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-114 in combination with subcutaneous (SC) amivantamab in patients with advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutation.', 'detailedDescription': 'ORIC-114, is a brain penetrant, selective, orally bioavailable, irreversible small molecule inhibitor designed to target EGFR exon 20 insertion mutations, making it a promising therapeutic candidate for development in patients whose tumors harbor these alterations, including those with CNS metastases.\n\nAmivantamab is a bispecific EGFR-directed and MET receptor-directed antibody indicated in combination with carboplatin and pemetrexed for the first line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations and also as a single agent in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.\n\nThis is an open-label, single arm, multicenter, dose escalation followed by dose expansion study to assess the safety and preliminary antitumor activity of ORIC-114 in combination with SC amivantamab, in patients with locally advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic NSCLC with a documented EGFR exon 20 insertion mutation as determined locally by any nucleic acid-based diagnostic testing method; all tests should be performed in a CLIA certified or equivalently accredited laboratory\n* Prior Therapies:\n\n 1. Dose Escalation: Patients may have previously received and progressed on or after platinum-based chemotherapy or may be treatment naïve\n 2. Dose Expansion: Patients must not have received any prior therapy; at time of enrollment, patients must decline, or be ineligible for all available standard of care therapies with proven benefit\n* Agreement and ability to undergo a pretreatment biopsy, provided the procedure is clinically feasible and not deemed unsafe by the investigator\n* Measurable disease according to RECIST 1.1\n* Patients with asymptomatic CNS metastases are eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Known small cell lung cancer transformation\n* Leptomeningeal disease\n* Spinal cord compression not definitively treated with surgery or radiation\n* Prior immunotherapy\n* Past medical history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD\n* Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably impact absorption of ORIC-114"}, 'identificationModule': {'nctId': 'NCT06816992', 'briefTitle': 'ORIC-114 in Combination with Subcutaneous Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'ORIC Pharmaceuticals'}, 'officialTitle': 'Phase 1b Study of ORIC-114 in Combination with Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC', 'orgStudyIdInfo': {'id': 'ORIC-114-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Dose Escalation level 1', 'description': 'ORIC-114 + amivantamab', 'interventionNames': ['Drug: ORIC-114 Dose 1 + amivantamab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Dose Escalation level 2', 'description': 'ORIC-114 + amivantamab', 'interventionNames': ['Drug: ORIC-114 Dose 2 + amivantamab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Dose Escalation level 3', 'description': 'ORIC-114 + amivantamab', 'interventionNames': ['Drug: ORIC-114 Dose 3 + amivantamab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Dose Expansion', 'description': 'Two potential ORIC-114 dose levels + amivantamab', 'interventionNames': ['Drug: ORIC-114 Dose 2 + amivantamab', 'Drug: ORIC-114 Dose 3 + amivantamab']}], 'interventions': [{'name': 'ORIC-114 Dose 1 + amivantamab', 'type': 'DRUG', 'description': 'ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection', 'armGroupLabels': ['Part 1 Dose Escalation level 1']}, {'name': 'ORIC-114 Dose 2 + amivantamab', 'type': 'DRUG', 'description': 'ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection', 'armGroupLabels': ['Part 1 Dose Escalation level 2', 'Part 2 Dose Expansion']}, {'name': 'ORIC-114 Dose 3 + amivantamab', 'type': 'DRUG', 'description': 'ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection', 'armGroupLabels': ['Part 1 Dose Escalation level 3', 'Part 2 Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Virginia Cancer Specialists', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '03000', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'M5G 1Z5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'facility': 'The Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'ORIC Clinical', 'role': 'CONTACT', 'email': 'clinical@oricpharma.com', 'phone': '650-388-5600'}], 'overallOfficials': [{'name': 'Pratik S. Multani, MD, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ORIC Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ORIC Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Janssen Research and Development LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}