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Profile Name | HRAS act mut |
Gene Variant Detail | |
Relevant Treatment Approaches |
Molecular Profile | Indication/Tumor Type | Response Type | Relevant Treatment Approaches | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|---|
HRAS act mut | salivary gland carcinoma | sensitive | Tipifarnib | Clinical Study | Actionable | In a clinical study, Zarnestra (tipifarnib) treatment resulted in an overall response rate of 8% (n=13) with one ongoing partial response with a duration of 14 months and stable disease as the best response in 58% (7/12) of evaluable patients with HRAS-mutant metastatic salivary gland carcinoma, and a median overall survival of 18 months, and a median progression-free survival of 7 months (PMID: 32557577). | 32557577 | |
HRAS act mut | transitional cell carcinoma | predicted - sensitive | Tipifarnib | Phase II | Actionable | In a Phase II trial, Zarnestra (tipifarnib) demonstrated safety and preliminary efficacy in patients with metastatic urothelial carcinoma harboring HRAS mutations (n=14) or STK11:rs2075606, 3 of 4 patients achieved progression-free survival at 6 months harbored HRAS activating mutations, and no response was observed in HRAS wild-type patients (J Clin Oncol 38: 2020 (suppl; abstr 5086); NCT02535650). | detail... | |
HRAS act mut | Advanced Solid Tumor | no benefit | Selumetinib | Clinical Study - Cohort | Actionable | In a Phase II trial (MATCH), Koselugo (selumetinib) treatment resulted in a 15% (3/20) six-month progression-free survival rate, no objective responses, and did not lead to tumor regression in pediatric patients with advanced solid tumors including high grade glioma (n=8) and rhabdomyosarcoma (n=7) that harbored MAPK pathway alterations including activating HRAS, KRAS, or NRAS mutations, BRAF V600E, or inactivating NF1 mutations (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 10008; NCT03213691, NCT03155620). | detail... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04487106 | Phase II | Azacitidine + Trametinib + Venetoclax | Azacitidine, Venetoclax, and Trametinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome | Recruiting | USA | 0 |
NCT04284774 | Phase II | Tipifarnib | Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial | Recruiting | USA | 1 |
NCT05340621 | Phase Ib/II | Binimetinib + OKI-179 | OKI-179 Plus Binimetinib in Patients With Advanced Solid Tumors in the RAS Pathway (Phase 1b) and NRAS-mutated Melanoma (Phase 2) | Recruiting | USA | 0 |
NCT04699188 | Phase Ib/II | JDQ443 JDQ443 + TNO155 JDQ443 + Spartalizumab JDQ443 + Spartalizumab + TNO155 | Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 9 |
NCT04418167 | Phase I | JSI-1187 Dabrafenib + JSI-1187 | JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations | Recruiting | USA | 0 |
NCT05111561 | Phase I | Binimetinib + ZEN-3694 | Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer | Recruiting | USA | 0 |
NCT02974803 | Phase II | Dabrafenib + Trametinib | Concurrent Dabrafenib + Trametinib With Sterotactic Radiation in BRAF Mutation-Positive Malignant Melanoma and Brain Metastases | Terminated | CAN | 0 |
NCT03973918 | Phase II | Binimetinib + Encorafenib | Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG (BRAF) | Active, not recruiting | USA | 0 |
NCT03919071 | Phase II | Dabrafenib + Trametinib | Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma | Recruiting | USA | 1 |
NCT02257424 | Phase Ib/II | Dabrafenib + Hydroxychloroquine + Trametinib | Dabrafenib, Trametinib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma (BAMM) | Completed | USA | 0 |
NCT03114319 | Phase I | TNO155 | Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors | Recruiting | USA | ESP | CAN | 5 |
NCT02097225 | Phase I | Dabrafenib + Onalespib + Trametinib | Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery | Active, not recruiting | USA | 0 |
NCT03310541 | Phase I | Capivasertib Capivasertib + Enzalutamide Capivasertib + Fulvestrant | AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations | Active, not recruiting | USA | 0 |