Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-02-23 @ 9:47 AM
Study NCT ID:
NCT06835569
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Sponsor:
Organization:
Raw JSON
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{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 188}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Up to 39 months', 'description': 'Number of participants that experience treatment-emergent adverse events (TEAEs).'}, {'measure': 'Dose Limiting Toxicities', 'timeFrame': '21 days', 'description': 'Number of participants with Dose Limiting Toxicities (DLTs).'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose', 'description': 'Cmax'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': 'Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose', 'description': 'Tmax'}, {'measure': 'Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)', 'timeFrame': 'Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose', 'description': 'AUCt'}, {'measure': 'Terminal Half-Life (t1/2)', 'timeFrame': 'Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 48 hours postdose', 'description': 't1/2'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 39 months', 'description': 'Assess per RECIST 1.1'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 39 months', 'description': 'Assess per RECIST 1.1'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to 39 months', 'description': 'Assess per RECIST 1.1'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 39 months', 'description': 'Assess per RECIST 1.1'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['KRAS mutation', 'NSCLC', 'Non-small cell lung cancer', 'Colorectal cancer', 'Pancreatic ductal adenocarcinoma', 'Colorectal carcinoma', 'Pancreatic cancer', 'Pancreatic carcinoma', 'Solid tumors', 'KRAS', 'Mutation', 'Metastatic', 'Advanced unresectable', 'Neoplasms', 'Neoplasms by Site', 'Carcinoma', 'Non-small cell lung carcinoma', 'Non-small cell lung neoplasm', 'Pancreatic neoplasm', 'Lung neoplasm', 'Colorectal neoplasm', 'Colon neoplasm', 'Mutant KRAS', 'KRAS amplification'], 'conditions': ['Cancer', 'PDAC - Pancreatic Ductal Adenocarcinoma', 'NSCLC (Non-small Cell Lung Cancer)', 'CRC (Colorectal Cancer)', 'Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.', 'detailedDescription': 'This is an open-label, multicenter, Phase 1/1b study of ALTA3263, an orally bioavailable KRAS isoform-selective inhibitor that inhibits multiple mutant forms of KRAS, in adults with advanced solid tumor malignancies with KRAS mutations. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA3263 as a monotherapy and as a combination regimen. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.\n* Unresectable or metastatic disease.\n* Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol\n* Known condition that prohibits the ability to swallow or absorb an oral medication.\n\nOther inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06835569', 'briefTitle': 'A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alterome Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations', 'orgStudyIdInfo': {'id': '3263-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALTA3263 monotherapy', 'description': 'ALTA3263 will be administered continuously at a protocol-defined dose based on cohort assignment', 'interventionNames': ['Drug: ALTA3263']}, {'type': 'EXPERIMENTAL', 'label': 'ALTA3263 in combination with cetuximab', 'description': 'ALTA3263 in combination with cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment', 'interventionNames': ['Drug: ALTA3263', 'Drug: cetuximab']}], 'interventions': [{'name': 'ALTA3263', 'type': 'DRUG', 'description': 'Oral ALTA3263 tablets will be administered at a protocol-defined dose', 'armGroupLabels': ['ALTA3263 in combination with cetuximab', 'ALTA3263 monotherapy']}, {'name': 'cetuximab', 'type': 'DRUG', 'description': 'Cetuximab injection for IV use will be administered at a protocol-defined dose', 'armGroupLabels': ['ALTA3263 in combination with cetuximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'centralContacts': [{'name': 'Alterome Clinical Trial Contact Center', 'role': 'CONTACT', 'email': 'clinical.trials@alterome.com', 'phone': '619-768-8189'}], 'overallOfficials': [{'name': 'Study Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alterome Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alterome Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}