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Profile Name HRAS mut PIK3CA M1043V
Gene Variant Detail

HRAS mutant (unknown)

PIK3CA M1043V (gain of function)

Relevant Treatment Approaches

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Clinical Trial Phase Therapies Title Recruitment Status
Clinical Trial Phase Therapies Title Recruitment Status
NCT01907815 Phase II Trametinib + Uprosertib Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Acute Myeloid Leukemia Terminated
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
NCT03190915 Phase II Trametinib Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia Recruiting
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 Recruiting
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
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
NCT04515394 Phase II Cetuximab + Tepotinib Study of Tepotinib Combined With Cetuximab in Participants Left-Sided Metastatic Colorectal Cancer (mCRC) Acquired Resistance Due to Mesenchymal Epithelial Transition (MET) Amplification Not yet recruiting
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 Recruiting
NCT04211337 Phase III Vandetanib Cabozantinib Selpercatinib A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531) Recruiting
NCT01449058 Phase Ib/II Alpelisib + Binimetinib A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors Completed
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
NCT01885195 Phase II Binimetinib MEK162 for Patients With RAS/RAF/MEK Activated Tumors Completed
NCT03043313 Phase II Trastuzumab + Tucatinib Tucatinib Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer Recruiting
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
NCT03051035 Phase I KO-947 First-in-Human Study of KO-947 in Non-Hematological Malignancies Active, not recruiting
NCT03377361 Phase Ib/II Ipilimumab + Nivolumab Ipilimumab + Nivolumab + Trametinib An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Patients With Previously Treated Cancer of the Colon or Rectum That Has Spread Active, not recruiting
NCT03919292 Phase Ib/II Divalproex sodium + Neratinib Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca Recruiting
NCT04145297 Phase I Hydroxychloroquine + Ulixertinib Ulixertinib (BVD-523) and Hydroxychloroquine in Patients w Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas (UTAH) Recruiting
NCT04566393 Expanded access Ulixertinib Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies Available
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
NCT03415126 Phase I ASN007 A Study of ASN007 in Patients With Advanced Solid Tumors Completed
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) Recruiting
NCT02022982 Phase Ib/II Palbociclib + PD-0325901 PALBOCICLIB + PD-0325901 for NSCLC & Solid Tumors Active, not recruiting
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
NCT03162627 Phase I Olaparib + Selumetinib Selumetinib and Olaparib in Solid Tumors Recruiting
NCT03983993 Phase II Niraparib + Panitumumab Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer (NIPAVect) Recruiting
NCT02747537 Phase II Irinotecan + Sorafenib Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With Sorafenib in Combination With Irinotecan Withdrawn
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
NCT02383927 Phase II Tipifarnib Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations Active, not recruiting
NCT03745326 Phase Ib/II Aldesleukin + anti-KRAS G12D mTCR cells + Cyclophosphamide + Fludarabine Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients Recruiting
NCT03069950 Phase II Dexamethasone + Floxuridine + Fluorouracil + Irinotecan + Leucovorin + Panitumumab Study of Chemotherapy With or Without Hepatic Arterial Infusion for Patients With Unresectable Metastatic Colorectal Cancer to the Liver Withdrawn
NCT03300609 Phase III Capecitabine Fluorouracil + Leucovorin + Oxaliplatin + Panitumumab Fluorouracil + Leucovorin + Panitumumab 5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab Terminated
NCT03384940 Phase II Trastuzumab deruxtecan DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01) Active, not recruiting
NCT01312857 Phase II Panitumumab Fluorouracil + Irinotecan + Leucovorin Floxuridine Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients With Wild Type RAS Who Have Resected Hepatic Metastases From Colorectal Cancer Active, not recruiting
NCT04429542 Phase I BCA101 BCA101 + Pembrolizumab Study of Safety and Tolerability of BCA101 Alone and in Combination With Pembrolizumab in Patients With EGFR-driven Advanced Solid Tumors Recruiting
NCT02508077 Phase II Fluorouracil + Irinotecan + Leucovorin Panitumumab FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer Terminated
NCT02573220 Phase I Cetuximab + Fluorouracil + Irinotecan + Leucovorin Irinotecan Hydrochloride With FOLFIRI and Cetuximab as First-Line Therapy in Treating Patients With RAS Wild-Type Colorectal Cancer Withdrawn
NCT03190941 Phase Ib/II Cyclophosphamide anti-KRAS G12V mTCR cells Fludarabine Aldesleukin Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Recruiting
NCT02613650 Phase I Binimetinib + Fluorouracil + Irinotecan + Leucovorin A Trial of mFOLFIRI With MEK162 in Patients With Advanced RAS (HRAS, NRAS, or KRAS) Positive Metastatic Colorectal Cancers Recruiting
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
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
NCT02974803 Phase II Dabrafenib + Trametinib Concurrent Dabrafenib + Trametinib With Sterotactic Radiation in BRAF Mutation-Positive Malignant Melanoma and Brain Metastases Active, not recruiting
NCT03114319 Phase I TNO155 Dose Finding Study of TNO155 in Adult Patients With Advanced Solid Tumors Recruiting
NCT03310541 Phase I Capivasertib Capivasertib + Enzalutamide Capivasertib + Fulvestrant AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations Active, not recruiting
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
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
NCT03973918 Phase II Binimetinib + Encorafenib Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG (BRAF) Recruiting
NCT03919071 Phase II Dabrafenib + Trametinib Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma Recruiting
NCT02257424 Phase Ib/II Dabrafenib + Hydroxychloroquine + Trametinib Dabrafenib, Trametinib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma (BAMM) Active, not recruiting
NCT01219699 Phase I Alpelisib Alpelisib + Fulvestrant A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene Completed
NCT03065062 Phase I Gedatolisib + Palbociclib Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors Recruiting
NCT02189174 Phase Ib/II CLR457 Study of CLR457 Administered Orally in Adult Patients With Advanced Solid Malignancies Terminated
NCT01708161 Phase I Alpelisib + Ganitumab A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors Terminated
NCT01396408 Phase II Temsirolimus Sunitinib A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours Active, not recruiting
NCT04586335 Phase I CYH33 + Olaparib Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Recruiting
NCT02761694 Phase I ARQ 751 + Paclitaxel ARQ 751 ARQ 751 + Fulvestrant ARQ 751 as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA / AKT / PTEN Mutations Active, not recruiting
NCT02920450 Phase Ib/II Carboplatin + Gedatolisib + Paclitaxel Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002) Terminated
NCT03941782 Phase 0 Alpelisib Compassionate Use of BYL 719 Alpelisib Available
NCT03213678 Phase II LY3023414 PI3K/mTOR Inhibitor LY3023414 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial) Recruiting
NCT03155620 Phase II Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) Recruiting
NCT02549989 Phase II LY3023414 Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer Active, not recruiting
NCT04317105 Phase Ib/II Copanlisib + Ipilimumab + Nivolumab Copanlisib + Nivolumab Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN Recruiting
NCT01833169 Phase II Buparlisib BKM120 for Patients With PI3K-activated Tumors Completed
NCT04108858 Phase Ib/II Copanlisib + Pertuzumab + Trastuzumab Pertuzumab + Trastuzumab Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer Recruiting
NCT04216472 Phase II Alpelisib + Nab-paclitaxel Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations Recruiting
NCT03842228 Phase I Copanlisib + Durvalumab + Olaparib Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations Recruiting
NCT04191499 Phase II Fulvestrant + Palbociclib Fulvestrant + GDC-0077 + Palbociclib A Study Evaluating the Efficacy and Safety of GDC-0077 + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer Recruiting
NCT01226316 Phase I Capivasertib Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules Active, not recruiting
NCT02340221 Phase III Fulvestrant + Taselisib Fulvestrant A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy (SANDPIPER) Active, not recruiting
NCT01776008 Phase II Goserelin + MK2206 Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer Terminated
NCT02465060 Phase II Erdafitinib Copanlisib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Pertuzumab + Trastuzumab Dabrafenib + Trametinib Binimetinib Adavosertib Osimertinib Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Larotrectinib Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting
NCT03218826 Phase I AZD8186 + Docetaxel PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery Recruiting
NCT02646319 Phase I Nab-Rapamycin Nanoparticle Albumin-Bound Rapamycin in Treating Patients With Advanced Cancer With mTOR Mutations Completed
NCT04208178 Phase III Pertuzumab + Trastuzumab Alpelisib + Pertuzumab + Trastuzumab Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation Recruiting
NCT02124148 Phase I Cisplatin + Prexasertib Cetuximab + Prexasertib Pemetrexed Disodium + Prexasertib LY3023414 + Prexasertib Fluorouracil + Leucovorin + Prexasertib A Study of Prexasertib (LY2606368) With Chemotherapy or Targeted Agents in Participants With Advanced Cancer Completed
NCT01470209 Phase I Buparlisib + Everolimus A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies Completed
NCT01437566 Phase II GDC-0980 Fulvestrant Pictilisib Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy Completed
NCT02961283 Phase I ASN003 Study of ASN003 in Subjects With Advanced Solid Tumors Terminated
NCT03834740 Phase I Everolimus + Ribociclib A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection Recruiting
NCT02644122 Phase II SF1126 SF1126 in Recurrent or Progressive SCCHN and Mutations in PIK3CA Gene and/or PI-3 Kinase Pathway Genes Terminated
NCT02728258 Phase II Copanlisib Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer Active, not recruiting
NCT03006172 Phase I GDC-0077 + Letrozole + Palbociclib GDC-0077 Fulvestrant + GDC-0077 GDC-0077 + Letrozole To Evaluate the Safety, Tolerability, and Pharmacokinetics of GDC-0077 Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer Recruiting
NCT02861300 Phase Ib/II Capecitabine + Telaglenastat CB-839 + Capecitabine in Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal Cancer Recruiting
NCT03297606 Phase II Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR) Recruiting
NCT03767335 Phase I CH5132799 + Fulvestrant + Trastuzumab CH5132799 + Trastuzumab MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer (B-PRECISE-01) Recruiting
NCT01928459 Phase I Alpelisib + Infigratinib Phase 1b Trial of BGJ398/BYL719 in Solid Tumors Completed
NCT02167854 Phase I Alpelisib + Elgemtumab + Trastuzumab Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer Active, not recruiting
NCT02987959 Phase II Sapanisertib Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas Active, not recruiting
NCT03056755 Phase II Alpelisib + Fulvestrant Alpelisib + Letrozole Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutation With Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (BYLieve) Recruiting
NCT03337724 Phase II Ipatasertib + Paclitaxel Paclitaxel A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (IPATunity130) Recruiting
NCT02315625 Phase II Everolimus Sunitinib Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery Terminated
NCT02576444 Phase II Adavosertib + Olaparib Olaparib Capivasertib + Olaparib AZD6738 + Olaparib OLAParib COmbinations (OLAPCO) Active, not recruiting
NCT01971515 Phase I M2698 First-in-Human Dose Escalation Trial in Subjects With Advanced Malignancies Completed
NCT01791478 Phase I Alpelisib + Letrozole BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer Active, not recruiting
NCT04495621 Phase Ib/II Cetuximab + CH5132799 MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01) (C-PRECISE-01) Recruiting
NCT03032406 Phase II Everolimus + Hydroxychloroquine Everolimus Hydroxychloroquine CLEVER Pilot Trial: A Phase II Pilot Trial of HydroxyChLoroquine, EVErolimus or the Combination for Prevention of Recurrent Breast Cancer Recruiting
NCT04192981 Phase I GDC-0084 GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases Recruiting
NCT00770263 Phase I Erlotinib + Temsirolimus Erlotinib and Temsirolimus for Solid Tumors Completed
NCT04251533 Phase III Alpelisib + Nab-paclitaxel Nab-paclitaxel Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss Without PIK3CA Mutation (EPIK-B3) Recruiting
NCT03457896 Phase II Cetuximab + Neratinib Neratinib + Trastuzumab Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status Recruiting
NCT01960023 Phase Ib/II Cetuximab + Neratinib Safety and Efficacy Study of Neratinib and Cetuximab to Treat Patients With Quadruple Wild-Type Metastatic Colorectal Cancer Withdrawn