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Profile Name | HRAS mutant |
Gene Variant Detail | |
Relevant Treatment Approaches |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
HRAS mut PIK3CA R88Q | high grade glioma | sensitive | Buparlisib + Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination therapy of Buparlisib (BKM120) and Koselugo (selumetinib) led to a synergistic effect, resulting in growth inhibition of astrocytoma cells with an HRAS mutation and expressing PIK3CA R88Q in culture, but at a higher drug concentration compared to cells without mutant HRAS (PMID: 29975751). | 29975751 |
HRAS mut PIK3CA E542K | high grade glioma | sensitive | Buparlisib + Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination therapy of Buparlisib (BKM120) and Koselugo (selumetinib) led to a synergistic effect, resulting in growth inhibition of astrocytoma cells with an HRAS mutation expressing PIK3CA E542K in culture, but at a higher drug concentration compared to cells without mutant HRAS (PMID: 29975751). | 29975751 |
HRAS mut PIK3CA M1043V | high grade glioma | sensitive | Buparlisib + Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination therapy of Buparlisib (BKM120) and Koselugo (selumetinib) led to a synergistic effect, resulting in growth inhibition of astrocytoma cells with an HRAS mutation and expressing PIK3CA M1043V in culture, but at a higher drug concentration compared to cells without mutant HRAS (PMID: 29975751). | 29975751 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT03698994 | Phase II | Ulixertinib | Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial) | Active, not recruiting | USA | 1 |
NCT04892017 | Phase Ib/II | DCC-3116 + Sotorasib Binimetinib + DCC-3116 DCC-3116 DCC-3116 + Trametinib | A Phase 1/2 Study of DCC-3116 as Monotherapy and Combination Therapy in Patients With MAPK Pathway Mutant Solid Tumors | Recruiting | USA | 0 |
NCT03162627 | Phase I | Olaparib + Selumetinib | Selumetinib and Olaparib in Solid Tumors | Recruiting | USA | 0 |
NCT05312398 | Phase II | Cetuximab + Fluorouracil + Irinotecan + Leucovorin Cetuximab + Irinotecan Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin | CAPRI 2 GOIM Study: Investigate the Efficacy and Safety of a Bio-marker Driven Cetuximab-based Treatment Regimen | Recruiting | ITA | 0 |
NCT03181100 | Phase II | Atezolizumab + Cobimetinib Atezolizumab + Bevacizumab Atezolizumab + Nab-paclitaxel Atezolizumab + Cobimetinib + Vemurafenib Atezolizumab + Paclitaxel | Atezolizumab With Chemotherapy in Treating Patients With Anaplastic or Poorly Differentiated Thyroid Cancer | Recruiting | USA | 0 |
NCT04800822 | Phase I | PF-07284892 Cetuximab + Encorafenib + PF-07284892 Lorlatinib + PF-07284892 Binimetinib + PF-07284892 | PF-07284892 in Participants With Advanced Solid Tumors | Recruiting | USA | 0 |
NCT04511845 | Phase I | SPYK04 | A Dose-Escalation Study of SPYK04 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion). | Recruiting | USA | 1 |
NCT04145297 | Phase I | Hydroxychloroquine + Ulixertinib | Ulixertinib (BVD-523) and Hydroxychloroquine in Patients w Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas (UTAH) | Recruiting | USA | 0 |
NCT04566393 | Expanded access | Ulixertinib | Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies | Available | USA | 0 |
NCT01885195 | Phase II | Binimetinib | MEK162 for Patients With RAS/RAF/MEK Activated Tumors | Completed | USA | 0 |
NCT03415126 | Phase I | ERAS-007 | A Study of ASN007 in Patients With Advanced Solid Tumors | Completed | USA | 0 |
NCT05057013 | Phase Ib/II | HMBD-001 | HMBD-001 in Advanced HER3 Positive Solid Tumours | Recruiting | 1 | |
NCT03983993 | Phase II | Niraparib + Panitumumab | Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer (NIPAVect) | Recruiting | USA | 0 |
NCT04211337 | Phase III | Vandetanib Cabozantinib Selpercatinib | A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 14 |
NCT02022982 | Phase Ib/II | Palbociclib + PD-0325901 | PALBOCICLIB + PD-0325901 for NSCLC & Solid Tumors | Active, not recruiting | USA | 0 |
NCT04072198 | Phase II | Bevacizumab + Fluorouracil + Irinotecan + Leucovorin + Nivolumab + Oxaliplatin | Nivolumab Plus FOLFOXIRI/Bevacizumab in First Line Chemotherapy of Advanced Colorectal Cancer RASm/BRAFm Patients (NIVACOR) | Recruiting | ITA | 0 |
NCT03051035 | Phase I | KO-947 | First-in-Human Study of KO-947 in Non-Hematological Malignancies | Terminated | USA | ESP | 0 |
NCT03190915 | Phase II | Trametinib | Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia | Recruiting | USA | 0 |
NCT03496766 | Phase II | Tipifarnib | Tipifarnib in Advanced Squamous NSCLC With Oncogen HRAS MutAtionS | Recruiting | ESP | 0 |
NCT04034173 | Phase II | Fluorouracil + Irinotecan + Leucovorin + Panitumumab | Optimal Anti-EGFR Treatment of mCRC Patients With Low-Frequency RAS Mutation | Not yet recruiting | DEU | 0 |
NCT04808362 | Phase Ib/II | OMO-103 | Phase 1/2 Study to Evaluate Safety, PK and Efficacy of the MYC-Inhibitor OMO-103 in Solid Tumours (MYCure) | Recruiting | ESP | 0 |
NCT02296242 | Phase Ib/II | Ulixertinib | Phase 1/2 Study of the ERK1/2 Inhibitor BVD-523 in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndromes | Completed | USA | 0 |
NCT03875820 | Phase I | Defactinib + RO5126766 | Phase I Trial of VS-6063 and RO5126766. (FRAME) | Recruiting | 1 | |
NCT03719690 | Phase II | Tipifarnib | Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy (AIM-HN/SEQ-HN) | Recruiting | USA | ITA | ESP | DEU | BEL | AUT | 12 |
NCT03213691 | Phase II | Selumetinib | Selumetinib Sulfate in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial) | Active, not recruiting | USA | 1 |
NCT03317119 | Phase I | Trametinib + Trifluridine-tipiracil hydrochloride | Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery | Active, not recruiting | USA | 0 |
NCT01449058 | Phase Ib/II | Alpelisib + Binimetinib | A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors | Completed | USA | ITA | FRA | ESP | 3 |
NCT03043313 | Phase II | Trastuzumab + Tucatinib Tucatinib | Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer | Active, not recruiting | USA | ITA | FRA | ESP | BEL | 0 |
NCT02747537 | Phase II | Irinotecan + Sorafenib | Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With Sorafenib in Combination With Irinotecan | Withdrawn | 0 | |
NCT04854434 | Phase II | Trifluridine-tipiracil hydrochloride Pembrolizumab + Selinexor Selinexor | A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations | Active, not recruiting | USA | 0 |
NCT02383927 | Phase II | Tipifarnib | Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations | Completed | USA | ITA | FRA | ESP | DEU | BEL | 4 |
NCT01306045 | Phase II | Erlotinib Lapatinib MK2206 Sunitinib Selumetinib | Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies | Active, not recruiting | USA | 0 |
NCT03714958 | Phase I | Siremadlin + Trametinib | Trametinib + HDM201 in CRC Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer Mutant and TP53 Wild-type (TRAHD) | Recruiting | FRA | 0 |
NCT01907815 | Phase II | Trametinib + Uprosertib | Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Acute Myeloid Leukemia | Terminated | USA | 0 |
NCT01737502 | Phase Ib/II | Auranofin + Sirolimus | Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer | Recruiting | USA | 0 |
NCT02292758 | Phase II | Bevacizumab + Cetuximab + Irinotecan Cetuximab + Irinotecan | Phase II Trial of Irinotecan, Cetuximab, and Bevacizumab Compared With Irinotecan, Cetuximab, and Placebo in KRAS-Wildtype, Irinotecan-Refractory, Metastatic Colorectal Cancer | Completed | USA | 0 |
NCT03919292 | Phase Ib/II | Divalproex sodium + Neratinib | Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca | Recruiting | USA | 0 |
NCT02224781 | Phase III | Ipilimumab + Nivolumab Dabrafenib + Trametinib | Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma | Active, not recruiting | USA | 0 |
NCT03913026 | Phase II | ECT-001 cord blood cells Mycophenolate mofetil Tacrolimus Cyclophosphamide + Fludarabine Cyclophosphamide + Fludarabine + Thiotepa | UM171 Expanded Cord Blood In Patients With High-Risk Acute Leukemia/Myelodysplasia | Recruiting | CAN | 0 |
NCT03867799 | Phase II | Nivolumab + Relatlimab | iSCORE: Immunotherapy Sequencing in COlon and REctal Cancer | Active, not recruiting | 1 | |
NCT05221320 | Phase II | Hydroxychloroquine + Ulixertinib | Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies | Recruiting | USA | 0 |
NCT04425239 | Phase II | Fluorouracil + Irinotecan + Leucovorin + Panitumumab | Intermittent or Continuous Panitumumab Plus FOLFIRI for RAS/B-RAF Wild-type Metastatic Colorectal Cancer (IMPROVE) | Completed | ITA | 0 |
NCT05217446 | Phase II | Pembrolizumab Cetuximab + Encorafenib + Pembrolizumab | A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer (SEAMARK) | Recruiting | USA | ITA | ESP | 3 |
NCT03244956 | Phase II | Trametinib Dabrafenib + Trametinib | Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer (MERAIODE) | Active, not recruiting | FRA | 0 |
NCT04776655 | Phase III | Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Cetuximab + Fluorouracil + Irinotecan + Leucovorin | Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB (LIBImAb) | Recruiting | ITA | 0 |
NCT02857270 | Phase I | LY3214996 Gemcitabine + LY3214996 + Nab-paclitaxel LY3214996 + Midazolam Abemaciclib + LY3214996 | A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer | Active, not recruiting | USA | FRA | 2 |
NCT05253651 | Phase III | Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab + Tucatinib Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin | A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03) | Recruiting | USA | 0 |
NCT04515394 | Phase II | Cetuximab + Tepotinib | Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE) | Terminated | USA | ITA | FRA | ESP | BEL | 3 |
NCT04310176 | Phase II | Bevacizumab + Capecitabine + Oxaliplatin Bevacizumab + Capecitabine Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil Bevacizumab + Fluorouracil + Valproic acid Bevacizumab + Capecitabine + Valproic acid Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin + Valproic acid Bevacizumab + Capecitabine + Oxaliplatin + Valproic acid | Valproic Acid in Combination With Bevacizumab and Oxaliplatin/Fluoropyrimidine Regimens in Patients With Ras-mutated Metastatic Colorectal Cancer (REVOLUTION) | Recruiting | ITA | 0 |