Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT06128551
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2023-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D001063', 'term': 'Appendiceal Neoplasms'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D021441', 'term': 'Carcinoma, Pancreatic Ductal'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'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': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002430', 'term': 'Cecal Neoplasms'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044584', 'term': 'Carcinoma, Ductal'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'None (Open Label)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'up to 3 years', 'description': 'Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs and vitals signs'}, {'measure': 'Dose Limiting Toxicities', 'timeFrame': '21 days', 'description': 'Number of participants with dose limiting toxicities'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Blood Concentration of RMC-6291 and RMC-6236', 'timeFrame': 'up to 21 weeks', 'description': 'Cmax'}, {'measure': 'Time to Reach Maximum Blood Concentration of RMC-6291 and RMC-6236', 'timeFrame': 'up to 21 weeks', 'description': 'Tmax'}, {'measure': 'Area Under Blood Concentration Time Curve of RMC-6291 and RMC-6236', 'timeFrame': 'up to 21 weeks', 'description': 'AUC'}, {'measure': 'Elimination Half-Life of RMC-6291 and RMC-6236', 'timeFrame': 'up to 21 weeks', 'description': 't1/2'}, {'measure': 'Ratio of accumulation of RMC-6291 and RMC-6236 from a single dose to steady state with repeated dosing', 'timeFrame': 'up to 21 weeks', 'description': 'accumulation ratio'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'up to 3 years', 'description': 'Overall response rate RECIST v1.1'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'up to 3 years', 'description': 'Duration of response per RECIST v1.1'}, {'measure': 'Disease Control Rate', 'timeFrame': 'up to 3 years', 'description': 'Disease Control rate per RECIST v1.1'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'up to 3 years', 'description': 'Time to response per RECIST v1.1'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'up to 3 years', 'description': 'Progression-free survival per RECIST v1.1'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RMC-6291', 'RAS (ON)', 'KRAS', 'KRASG12C', 'KRASG12C (ON)', 'Targeted therapy', 'Metastatic Cancer', 'Lung Cancer', 'Lung Neoplasms', 'Thoracic Neoplasms', 'Non-small Cell Lung Cancer', 'Carcinoma, Non-Small Cell Lung', 'NSCLC', 'Colorectal Cancer', 'Colonic Neoplasms', 'CRC', 'Appendiceal Cancer', 'KRAS mutation', 'STK11/LKB1', 'KEAP1', 'Bronchial neoplasms', 'Respiratory tract neoplasms', 'Neoplasms by site', 'Neoplasms', 'Colon Cancer', 'Rectal Cancer', 'Lung disease', 'Respiratory tract diseases', 'Pancreatic Cancer', 'Carcinoma, Pancreatic Ductal', 'PDAC', 'Gastrointestinal Neoplasms', 'Intestinal Neoplasms', 'Esophageal Cancer', 'Ampullary Cancer', 'Gastric Cancer', 'Gynecological Cancer', 'Ovarian Cancer', 'Endometrial Cancer', 'RMC-6236'], 'conditions': ['Non-Small Cell Lung Cancer (NSCLC)', 'Colorectal Cancer', 'Pancreatic Ductal Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '40056080', 'type': 'DERIVED', 'citation': 'Cregg J, Edwards AV, Chang S, Lee BJ, Knox JE, Tomlinson ACA, Marquez A, Liu Y, Freilich R, Aay N, Wang Y, Jiang L, Jiang J, Wang Z, Flagella M, Wildes D, Smith JAM, Singh M, Wang Z, Gill AL, Koltun ES. Discovery of Daraxonrasib (RMC-6236), a Potent and Orally Bioavailable RAS(ON) Multi-selective, Noncovalent Tri-complex Inhibitor for the Treatment of Patients with Multiple RAS-Addicted Cancers. J Med Chem. 2025 Mar 27;68(6):6064-6083. doi: 10.1021/acs.jmedchem.4c02314. Epub 2025 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety, tolerability, and PK profiles of RMC-6291 and RMC-6236 in adults with KRAS G12C-mutated solid tumors.', 'detailedDescription': 'This is an open-label, multicenter, Phase 1b study of RMC-6291 in combination with RMC-6236 in participants with advanced KRAS G12C-mutated solid tumors, to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose and schedule (RP2DS) and provide a preliminary assessment of the antitumor activity of RMC-6291 in participants with KRASG12C tumors.\n\nThe study consists of two parts: Part 1 - Dose-Escalation and Part 2 Dose-Expansion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '125 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age\n* Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy\n\n 1. Part 1. Dose Escalation: solid tumors, previously treated\n 2. Part 2. Dose Expansion:\n\n i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors, ii. NSCLC, previously treated with immunotherapy and chemotherapy, naïve to KRAS G12C (OFF) inhibitors, iii. NSCLC, previously treated with immunotherapy, chemotherapy, with untreated, asymptomatic central nervous system (CNS) metastases \\<2 cm in size iv. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.\n* ECOG performance status 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Primary central nervous system (CNS) tumors\n* Active brain metastases\n* Known impairment of GI function that would alter the absorption\n* Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment'}, 'identificationModule': {'nctId': 'NCT06128551', 'briefTitle': 'Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Revolution Medicines, Inc.'}, 'officialTitle': 'Phase 1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors', 'orgStudyIdInfo': {'id': 'RMC-6291-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RMC-6291 and RMC-6236', 'description': 'Dose escalation and Dose expansion', 'interventionNames': ['Drug: Assigned interventions']}], 'interventions': [{'name': 'Assigned interventions', 'type': 'DRUG', 'description': 'Drug: RMC-6291 and RMC-6236 Oral tablets', 'armGroupLabels': ['RMC-6291 and RMC-6236']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UC IRVINE Health', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UC Davis Comprehensive Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Stanford Cancer Institute', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 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