Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination with Cetuximab and Encorafenib in Patients with Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy

To find the recommended dose of ulixertinib that can be given in combination with cetuximab and/or encorafenib to patients with unresectable/metastatic CRC and who have received EGFR or BRAF-directed therapy in the past.

Start Date18 Jan 2024

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+2]

NCT05804227 / RecruitingEarly Phase 1IIT

Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Low-Grade Gliomas in Adults

To learn if the study drug, ulixertinib, can cross over the blood-brain barrier in patients with recurrent brain tumors

Start Date20 Apr 2023

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

100 Clinical Results associated with Ulixertinib

100 Translational Medicine associated with Ulixertinib

100 Patents (Medical) associated with Ulixertinib

Literatures (Medical) associated with Ulixertinib

11 Oct 2024·Current Medicinal Chemistry

FOXN3-AS1: A Candidate Prognostic Marker and Epigenetic Target with Immunotherapeutic Implications in Acute Myeloid Leukemia

Article

Author: Schmidt-Wolf, Ingo G.H. ; Ge, Fangfang ; Huang, Xiaoli ; Wang, Yulu ; Wang, Zifeng ; Chen, Peng ; Sharma, Amit ; Dakal, Tikam Chand ; Essler, Markus ; Jaehde, Ulrich ; Schmid, Matthias

Aim:We focused on the FOXN3 gene and selected its antisense transcripts (FOXN3-AS1) to investigate its potential involvement in acute myeloid leukemia (AML).Background:Several integrated multi-omics datasets have expanded the horizons of the cancer landscape. With the emergence of new high-throughput technologies, a large number of non-coding RNAs have been confirmed to be involved in the pathogenesis of different types of hematological malignancies.Methods:We conducted experimental validation using quantitative polymerase chain reaction (qPCR) with bone marrow specimens from AML patients. Then, Kaplan-Meier (KM) and Receiver Operating Characteristic (ROC) curves were used to substantiate the prognostic association between FOXN3-AS1 and AML patients within the TCGA database. Correlation between FOXN3-AS1 expression and gene mutation, immune, and immune function using Spearman correlation analysis. To explore the physical and functional interaction between FOXN3-AS1 and the DNMT1 protein, we utilized the RPISeq web tool from Iowa State University. Subsequently, we performed qPCR experiments to test the effect of 5AzaC (DNMT1 inhibitor) on FOXN3-AS1 expression AML cell lines (THP1 and OCI-AML3). We leveraged the “OncoPredict” R package in conjunction with the Genomics of Drug Sensitivity (GDSC) database to predict drug response in AML patients expressing FOXN3-AS1.Results:We observed a significant upregulation of FOXN3-AS1 expression in AML patients compared to healthy controls using clinical samples. The TCGA database revealed an association between high FOXN3-AS1 expression and adverse prognosis. In our subsequent analysis, genes with poor prognostic implications in AML patients were exclusively identified in the FOXN3-AS1 high-expression group, further corroborating this relationship. AML patients with higher FOXN3-AS1 expression levels may respond less optimally to immunotherapy than patients with lower levels. Besides, we computationally predicted the interaction of FOXN3- AS1 and DNMT1 protein and experimentally confirmed that DNMT1i (GSK-3484862) affects the expression level of FOXN3-AS1. We also found that the chemotherapy drugs (5-Fluorouralic, Cisplatin, Dactolisib, Sapitinib, Temozolomide, Ulixertinib, Vinorelbine, Ruxolitinib, Osimertinib and Cisplatin) showed favorable responses in AML patients with high FOXN3-AS1 expression levels.Conclusion:Our candidate approach identifies FOXN3-AS1 as a prognostic indicator of survival in AML with a potential immune-related role. The preliminary observations we made on FOXN3-AS1/DNMT1 crosstalk warrant more in-depth invested immunotherapeutic approaches in AML.

01 Jun 2024·JCO Precision Oncology

Phase II Study of Ulixertinib in Children and Young Adults With Tumors Harboring Activating Mitogen-Activated Protein Kinase Pathway Alterations: APEC1621J of the National Cancer Institute-Children's Oncology Group Pediatric MATCH Trial

Article

Author: Parsons, D. Williams ; Janeway, Katherine A. ; Tricoli, James V. ; Takebe, Naoko ; Roy-Chowdhuri, Sinchita ; Saguilig, Lauren ; Hawkins, Douglas S. ; Reid, Joel M. ; Alonzo, Todd A. ; Patton, David R. ; Seibel, Nita L. ; Coffey, Brent ; Sabnis, Amit J. ; Piao, Jin ; Jaju, Alok ; Vo, Kieuhoa T. ; Berg, Stacey L. ; Mooney, Margaret M. ; Fox, Elizabeth ; Williams, P. Mickey ; Weigel, Brenda J.

PURPOSE The National Cancer Institute-Children's Oncology Group (NCI-COG) Pediatric MATCH trial assigns patients age 1-21 years with refractory malignancies to phase II treatment arms of molecularly targeted therapies on the basis of genetic alterations detected in their tumor. Patients with activating alterations in the mitogen-activated protein kinase pathway were treated with ulixertinib, an extracellular signal-regulated kinase (ERK)1/2 inhibitor. METHODS As there were no previous pediatric data, ulixertinib was initially tested in a dose escalation cohort to establish the recommended phase II dose (RP2D) before proceeding to the phase II cohort. Ulixertinib was administered at 260 mg/m2/dose orally twice a day (dose level 1 [DL1], n = 15) or 350 mg/m2/dose orally twice a day (DL2, n = 5). The primary end point was objective response rate; secondary end points included safety/tolerability and progression-free survival (PFS). RESULTS Twenty patients (median 12 years; range, 5-20) were treated, all evaluable for response. CNS tumors comprised 55% (11/20) of diagnoses, with high-grade glioma and low-grade glioma most common (n = 5 each). All CNS tumors except one harbored BRAF fusions or V600E mutations. Rhabdomyosarcoma (n = 5) was the most frequent non-CNS diagnosis. DL1 was declared the RP2D in the dose escalation cohort after dose-limiting toxicities in Cycle 1 occurred in 1/6 patients at DL1 and 2/5 patients at DL2, including fatigue, anorexia, rash, nausea, vomiting, diarrhea, dehydration, hypoalbuminemia, and hypernatremia. No objective responses were observed. Six-month PFS was 37% (95% CI, 17 to 58). Three patients with BRAF-altered CNS tumors achieved stable disease >6 months. CONCLUSION Ulixertinib, a novel targeted agent with no previous pediatric data, was successfully evaluated in a national precision medicine basket trial. The pediatric RP2D of ulixertinib is 260 mg/m2/dose orally twice a day. Limited single-agent efficacy was observed in a biomarker-selected cohort of refractory pediatric tumors.

21 May 2024·Cancer Research Communications

A Phase II Study of ERK Inhibition by Ulixertinib (BVD-523) in Metastatic Uveal Melanoma

Article

Author: Cohen, Justine V. ; Buchbinder, Elizabeth I. ; Sullivan, Ryan J. ; Liu, David ; Lian, Christine G. ; Knoerzer, Deborah ; Lawrence, Donald P. ; Haq, Rizwan ; Tarantino, Giuseppe ; Giobbie-Hurder, Anita ; Hodi, F. Stephen

AbstractPurpose:Uveal melanoma is a rare and aggressive subset of melanoma that is minimally responsive to traditional therapies. Greater than 80% of uveal melanomas have a mutation in GNAQ or GNA11 which lead to downstream signaling through the MAPK pathway. Ulixertinib (BVD-523) is a potent and reversible small-molecule ATP-competitive inhibitor of both ERK1 and ERK2 protein kinases.Materials and Methods:We performed a phase II study to determine the efficacy and safety of BVD-523 in patients with metastatic uveal melanoma. This was conducted as a Simon two-stage design with a sample size of 25 patients and an initial evaluation of efficacy after 13 patients.Results:From April 2018 to April 2019, 13 patients were enrolled. Patients were predominantly female (69%) with a median age of 64 years (34–76). Sites of metastases included liver (84.6%) and lung (30.8%). Grade 3 and 4 toxicities associated with therapy were consistent with ERK inhibitors and included liver function test (LFT) elevation, hyponatremia, pruritis, amylase elevation, anemia, and rash. The best response, per RECIST 1.1, was stable disease in 4 patients, and disease progression in 7 patients. Two patients were unevaluable for response due to withdrawal from study. Median time to progression was 2.0 months. There were eight deaths due to disease progression with a median overall survival of 6.9 months.Conclusions:ERK inhibition with ulixertinib (BVD-523) did not demonstrate activity in patients with metastatic uveal melanoma. The toxicities observed were consistent with what would be expected with MAPK pathway inhibition.Significance:Uveal melanoma is a difficult to treat disease with minimal therapy options. The majority of uveal melanomas have mutations in GNAQ or GNA11 leading to activation of the MAPK pathway. Efforts to target MEK in uveal melanoma has had mixed results. This phase II trial of ERK inhibition with BVD-523 examined the potential role of this agent in uveal melanoma therapy.

News (Medical) associated with Ulixertinib

23 Mar 2023

·www.prnewswire.com

Clarivate Announces Gordon Samson as President, Intellectual Property and Nominates Dr. Saurabh Saha as New Independent Director

Naming the first of three business leaders for its newly created market segments and nominating new Independent Director to its Board LONDON, March 23, 2023 /PRNewswire/ -- Clarivate Plc (NYSE: CLVT), a global leader in connecting people and organizations to intelligence they can trust, today announced that Gordon Samson, currently Chief Product Officer, has been appointed President of its Intellectual Property (IP) market segment, effective April 1. The Company also announced that it has nominated Dr. Saurabh Saha to stand for election as a director at its 2023 Annual General Meeting of shareholders on May 4, 2023. Jonathan Gear, Chief Executive Officer, Clarivate said: "I'm very pleased to announce the appointment of Gordon who has been a trusted and valued member of our Executive Leadership Team since he came to Clarivate from CPA Global as part of our acquisition in 2020. In this newly created role, he will be responsible for accelerating the growth of our IP segment empowering customers to establish, protect and manage their IP. Based on my experience working with him over the last eight months and the work we've done this year to align the organization, I'm confident that he will be instrumental to how we capitalize on product and service innovation to deliver organic growth. This is the first of our presidential appointments and we look forward to providing updates on further appointments in due course." Samson joined Clarivate in October 2020 with the acquisition of CPA Global, having joined CPA Global in 2014 as Chief Operating Officer. During the last three years with Clarivate, Samson has made significant contributions, helping transform the Company's APAC region and bringing together the Company's entire product portfolio to offer customers a full range of enriched data, insights, analytics and workflow solutions. He has a long and successful track record of driving organizational transformation and growth in the IP industry and beyond, having held senior executive roles with both operating and P&L accountability for more than 20 years. Andy Snyder, Chairman of the Board, Clarivate commented: "We look forward to Dr. Saha joining our Board. He will bring a great deal of experience in the pharmaceutical and biotech industries and his guidance will provide valuable insights and perspective, especially as we continue to execute on our growth strategy in the Life Sciences & Healthcare segment." Dr. Saha is a physician-scientist, pharmaceutical executive, and biotech entrepreneur dedicated to discovering and developing novel life-changing medicines. He is notable for leading the development and demonstrating human effectiveness of two innovative cancer drugs, an ERK kinase inhibitor (Ulixertinib) and an oncolytic immunotherapy (C. novyi-NT). He is currently CEO of Centessa Pharmaceuticals (NASDAQ: CNTA), a global pharma company. Prior to Centessa, Dr. Saha was a Senior Vice President of R&D and Global Head of Translational Medicine for all disease areas at Bristol Myers Squibb. Other past roles include Venture Partner at Atlas Venture, a VC firm in Cambridge MA, Chief Executive Officer at Delinia, Chief Medical Officer of Synlogic, a management consultant at McKinsey & Company, and head of the New Indications Discovery Unit at Novartis. He is an associate member and Global Clinical Scholar at Harvard Medical School, holds an MD and PhD in medicine and cancer genetics from The Johns Hopkins School of Medicine, an MSc in biophysics from the University of Oxford and a BSc in biochemistry from Caltech. About Clarivate Clarivate™ is a leading global information services provider. We connect people and organizations to intelligence they can trust to transform their perspective, their work and our world. Our subscription and technology-based solutions are coupled with deep domain expertise and cover the areas of Academia & Government, Life Sciences & Healthcare and Intellectual Property. For more information, please visit clarivate.com. Investor Relations Contact Mark Donohue, Head of Investor Relations, [email protected], +1 (215) 243 2202 Media Contact Amy Bourke-Waite, Senior Director, Corporate Communications, [email protected] SOURCE Clarivate Plc

Executive Change

12 Sep 2022

·www.prnewswire.com

BioMed Valley Discoveries Announces First Patient Dosed in Phase II Combination Trial with Ulixertinib (BVD-523), its First-in-Class and Best-in-Class ERK Inhibitor, in Combination with Hydroxychloroquine

KANSAS CITY, Mo., Sept. 12, 2022 /PRNewswire/ -- BioMed Valley Discoveries (BVD) announced that the first patient has been dosed in a phase II clinical trial of ulixertinib (BVD-523) in combination with hydroxychloroquine (HCQ). Ulixertinib is a first-in-class and best-in-class ERK inhibitor, with this clinical trial focusing on patients with advanced gastrointestinal malignancies and mutations in the MAPK pathway. This study builds upon the finding of the phase I study of the combination, which was completed at Huntsman Cancer Institute at the University of Utah. "Combining an ERK inhibitor with an autophagy inhibitor is anticipated to take advantage of the finding that tumors may become addicted to autophagy for survival in context of MAPK inhibition" said Brent Kreider, Ph.D., President of BioMed Valley Discoveries. "Given the favorable safety profile and efficacy seen with ulixertinib monotherapy, we believe that the combination with hydroxychloroquine has the potential to provide significant benefit to patients with advanced gastrointestinal malignancies." The Phase II efforts build on a successful Phase Ib evaluating ulixertinib monotherapy as a novel targeted cancer treatment in cohorts of patients with genetic alterations that result in aberrant MAPK pathway signaling. Results from phase Ib demonstrated ulixertinib has an acceptable safety profile and early evidence of clinical activity against a wide range of RAS/MAPK pathway-driven cancers, including atypical alterations in BRAF. In addition to targeting the terminal node of the RAS/MAPK pathway, ulixertinib's highly selective kinase inhibition profile is expected to provide potential impact across a number of tumor types in both monotherapy and combination. Previous efforts have also established a recommended phase 2 dose in combination with palbociclib, with additional combination efforts ongoing. About ulixertinib (BVD-523): Ulixertinib is a first-in class and best-in class small molecule inhibitor of extracellular signal-regulated kinase (ERK) family kinases (ERK1 and ERK2) that is being developed as a novel anti-cancer drug. ERK kinases are downstream components of the mitogen-activated protein kinase (MAPK) signaling cascade (RAS-RAF-MEK-ERK). Ulixertinib has demonstrated promising early efficacy for patients with tumors harboring alterations in the MAPK pathway. About the study: This is an open-label, multicenter, prospective phase II basket trial assessing the efficacy of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies. All patients recruited must have a mitogen-activated protein kinase (MAPK) activating mutation to be deemed eligible for trial participation. Each disease-based basket will open to enrollment in two-stages and includes pancreatic, colorectal, esophageal, gastric and cholangiocarcinomas . (Clinicaltrials.gov Number NCT05221320). About BioMed Valley Discoveries (BVD): BioMed Valley Discoveries is a clinical stage biotechnology company focused on addressing unmet medical needs in a variety of therapeutic and diagnostic areas. In addition to the ERK inhibitor, BVD's portfolio includes an oncolytic bacteria that has completed enrollment for a Phase I study, and two early-stage antibodies targeting the tumor microenvironment. Operating since 2007, BioMed Valley Discoveries was established by Jim Stowers Jr., founder of the asset management firm American Century Investments, and his wife Virginia, to advance new medical innovations to improve the lives of patients with difficult-to-treat diseases. BVD is owned by a supporting organization of the Stowers Institute for Medical Research, a non-profit, basic biomedical research organization. Since 2000, the endowment of the Stowers Institute has received over $1.7 billion in dividend payments from American Century. The Institute has invested a portion of its endowment in BVD, whose profits accrue to the benefit of the Institute. For more information, visit . Media Contact Joe Chiodo, Head of Media Relations 724-462-8529 [email protected] SOURCE BioMed Valley Discoveries

AntibodyCollaborateFirst in ClassSmall molecular drug

06 Jan 2021

·www.biospace.com

Theralink® Technologies Issues Letter to Shareholders

DENVER, Jan. 6, 2021 /PRNewswire/ -- Theralink Technologies (OTC: OBMP) ("Theralink" or the "Company"), a molecular profiling company specializing in patented, biomarker assay services that target multiple areas of oncology, today issued a letter to shareholders from its President and CEO, Mick Ruxin, M.D., providing a 2020 year-end recap and vision for the path ahead in 2021. Dear Shareholders: 2020 was a transformative year for Theralink Technologies. In June, we successfully closed OncBioMune Pharmaceuticals' asset purchase of Avant Diagnostics and changed the corporate name to Theralink® Technologies Inc. In September, Theralink emerged as a proteomics-based, molecular profiling and precision medicine company targeting multiple areas of oncology and drug development. Going forward we will continue to work on several other key aspects of our evolution as a public company, including our stock symbol change and updated financial statements with the SEC, which we anticipate to all be completed during the first half of 2021. In addition to my appointment as President and CEO, we have added experienced professionals to our leadership team through three key hires. We welcomed Kris Weinberg as Director of Commercial Oncology Markets, Michael Fanelli as Senior Director of Biopharma Commercial Operations and Tom Chilcott as Chief Financial Officer, who all bring extensive experience in their respective fields and have hit the ground running as part of our team. Over the past six-months, we have worked diligently to lay the foundation for our growth in 2021. Notably, we received Clinical Laboratory Improvement Amendments (CLIA) certification for our Golden, Colorado laboratory, which took two years to achieve. CLIA certification enables us to expand our testing capabilities and we will soon begin receiving, testing and billing for patient's breast cancer tumor specimens. As part of our growth strategy ahead, we have established several strategic agreements: In July, we announced a multi-year strategic agreement with VieCure™, the developer of the proprietary VieCure™ platform, a real-time decision-support system that combines clinical knowledge with patient data to assist oncologists in generating personalized treatment plans and managing a patient's care throughout his or her cancer therapy. Through our agreement, VieCure's physician network has access to Theralink's generation of testing for cancer patients, extending VieCure™'s genomics platform to now include phosphoprotein and protein-based information. We believe that the potential reach of their physician network leveraging our assay is substantial. In September, we announced our translational research collaboration with BioMed Valley Discoveries (BVD) to provide Laser Capture Microdissection (LCM) and Reverse Phase Protein Array (RPPA) services to assist BVD with translational research. We believe that this research could potentially improve treatment outcomes and quality of life for all cancer patients. In November 2020, we announced our agreement with Perthera, a market leader in Precision Oncology technology and services whose platform has been utilized by over 250 cancer care sites. The alliance was formed to facilitate and accelerate access to Theralink's 32 phosphoprotein panel, the Theralink® assay, across Perthera's wide reach in the U.S. for breast cancer patients and the oncologists who treat them. With many key milestones under our belt for 2020, there remains no shortage of opportunity as we head into 2021. In addition to the signing of our translational research collaboration with BioMed Valley Discoveries in September 2020, we have successfully signed multiple other biopharma collaboration agreements to date, all of which are generating revenue. In 2021, we not only expect to expand these existing relationships, but we will also continue to sign multiple other collaborative agreements. Thank you for your continued support and commitment. The Theralink team looks forward to a prosperous 2021! Sincerely, Mick Ruxin, M.D. President and CEO Corporate Milestones: OncBioMune Pharmaceuticals closed the asset purchase of Avant Diagnostics in June 2020 - link In September 2020, the Company received Clinical Laboratory Improvement Amendments (CLIA) certification for its Golden, Colorado laboratory, retroactively effective as of January 8, 2020 – link As of Thursday, September 24, 2020 the Company completed its corporate name change to Theralink Technologies, Inc. – link Enhanced Leadership: In June 2020, we appointed Mick Ruxin, M.D. as President & CEO and Jeffrey Busch as Chairman of the Board – link Also In June 2020, we appointed Kris Weinberg as Director, Oncology Commercial Markets. Mr. Weinberg has 20 years of experience in the commercial aspects of cancer molecular diagnostics, leading the launch and adoption of oncology assays including OncoType Dx and Guardant 360. Prior to TheraLink, he was commercial lead for TGen's CLIA NGS laboratory (Ashion) and Natera's oncology division. Also, Mr. Weinberg has previous public company experience at IMPATH, Genomic Health and Guardant Health. In July 2020, we appointed Michael Fanelli as Senior Director of Biopharma Commercial Operations – link In September 2020, we appointed Thomas E. Chilcott, III CPA as Chief Financial Officer – link Strategic Agreements: In July 2020, the Company signed a mutli-year strategic agreement with VieCure™ to enhance personalized cancer treatment in community oncology settings – link In September 2020, the Company announced its translational research collaboration with BioMed Valley Discoveries (BVD) to provide Laser Capture Microdissection (LCM) and Reverse Phase Protein Array (RPPA) services to assist BVD with translational research pertaining to first-in-class and best-in-class ERK 1/2 Inhibitor – Ulixertinib (BVD-523) – link In November 2020, the Company announced its agreement with Perthera, a market leader in Precision Oncology technology and services. The alliance was formed to facilitate and accelerate access to Theralink's 32 phosphoprotein panel, the Theralink assay, across the U.S. for breast cancer patients – link About Theralink Technologies, Inc. Theralink® Technologies is a proteomics-based, molecular profiling and precision medicine company with a CLIA-certified laboratory located in Golden, Colorado. Through its unique and patented phosphoprotein and protein biomarker platform and LDTs, Theralink's technology targets multiple areas of oncology and drug development. Theralink provides precision oncology data through its powerful Theralink® Reverse Phase Protein Array (RPPA) assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders and non-responders to both FDA-approved and investigational drug treatments. Theralink intends to help improve cancer outcomes for patients, reveal therapeutic options for oncologists, and support biopharmaceutical drug development by using a beyond-genomics approach to molecular profiling that directly measures drug target levels and activity. For more information, please visit . Forward-Looking Statements Certain statements contained in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, anything relating or referring to future financial results, patient enrollment and plans for future business development activities, and are thus prospective. Forward-looking statements are inherently subject to risks and uncertainties some of which cannot be predicted or quantified based on current expectations. Such risks and uncertainties include, without limitation, the risks and uncertainties set forth from time to time in reports filed by Theralink Technologies with the Securities and Exchange Commission. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business and although the company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to have been correct. Consequently, future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward the forward-looking statements contained herein. The company undertakes no obligation to publicly release statements made to reflect events or circumstances after the date hereof. Company Codes: OTC-PINK:OBMP

CollaborateFinancial StatementFirst in Class

100 Deals associated with Ulixertinib

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D11038	-	-	DB13930

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteosarcoma, Recurrent	Phase 2	PR	National Cancer Institute	14 Nov 2018
Osteosarcoma, Recurrent	Phase 2	US	National Cancer Institute	14 Nov 2018
Recurrent Non-Hodgkin Lymphoma	Phase 2	US	National Cancer Institute	14 Nov 2018
Recurrent Non-Hodgkin Lymphoma	Phase 2	PR	National Cancer Institute	14 Nov 2018
Rhabdomyosarcoma	Phase 2	PR	National Cancer Institute	14 Nov 2018
Rhabdomyosarcoma	Phase 2	US	National Cancer Institute	14 Nov 2018
Uveal Melanoma	Phase 2	US	BioMed Valley Discoveries, Inc.	26 Mar 2018
Advanced cancer	Phase 2	US	BioMed Valley Discoveries, Inc.	01 Mar 2013
Acute Myeloid Leukemia	Phase 2	-	Vertex Pharmaceuticals, Inc.	-
Myelodysplastic Syndromes	Phase 2	-	Vertex Pharmaceuticals, Inc.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04488003 (CTgov)	Phase 2	Advanced Malignant Solid Neoplasm	104	Ulixertinib	tdentdheej(wpayyqubvw) = kgfpfpsqfu imlxgiuual (ubifbpubfn, yrxbfpkxni - kuvjsgamqh) View more	-	04 Jun 2024
NCT03698994 (CTgov)	Phase 2	Refractory Soft Tissue Sarcoma \| Recurrent Medulloblastoma \| Ependymoma \| Refractory Histiocytic and Dendritic Cell Neoplasm \| Relapsed Solid Neoplasm \| Refractory Medulloblastoma \| Non-Hodgkin's lymphoma refractory \| Wilms Tumor \| Advanced Malignant Solid Neoplasm \| Refractory Langerhans Cell Histiocytosis \| Recurrent Histiocytic and Dendritic Cell Neoplasm \| Refractory Malignant Germ Cell Tumor \| Refractory Osteosarcoma \| Rhabdomyosarcoma \| Refractory Malignant Solid Neoplasm \| Hepatoblastoma \| Rhabdoid Tumor \| Recurrent Glioma \| Recurrent Non-Hodgkin Lymphoma \| Osteosarcoma, Recurrent \| Neuroblastoma recurrent \| Recurrent Ewing Sarcoma \| Refractory Neuroblastoma \| Refractory Ewing Sarcoma	20	Pharmacokinetic Study+Ulixertinib	bykayirrcx(naecdrrmem) = dnafavsdkz hcgxlzxqzy (qhgqwownup, nnciexiwnn - jsvicqgwtj) View more	-	16 May 2023
NCT02608229 (Pubmed) Manual	Phase 1	Pancreatic adenocarcinoma metastatic	18	Albumin-Bound Paclitaxel+Gemcitabine+Ulixertinib	(krcnvizjwh) = ulixertinib 450 mg BID zkbrdsrzjh (yqmqglctnn )	Positive	25 Nov 2022
NCT02465060 (EAY131-Z1L, AACR2022) Manual	Phase 1	Neoplasms BRAF Fusion	35	BVD-523FB	(frlmqyjjts) = rvausjjmny mjntdvhzol (alogcpcell ) View more	Positive	15 Jun 2022
NCT04566393 (ULI-EAP-100, ASCO2022) Manual	Not Applicable	HR-positive/HER2-low Solid Tumors MAPK Mutation	48	ulixertinib	(mcvjllisgv) = psalbminbh frjzfbblvt (yqlzrelwgj ) View more	Positive	02 Jun 2022
NCT03698994 (ASCO2022) Manual	Phase 2	Neoplasms MAPK Mutation	20	overall	(jnzyocrmqc) = xfshhjosun nteipqwzcd (vvabznzrmo, 17 - 58) View more	Positive	02 Jun 2022
NCT03698994 (ASCO2022) Manual	Phase 2	Neoplasms MAPK Mutation	20	Ulixertinib 260 mg/m2 (DL1)	(lrzyifxvpr) = vhzzbouurr glxrhclqct (ytcepcdkyt )	Positive	02 Jun 2022
NCT03417739 (CTgov)	Phase 2	Uveal Melanoma	13	BVD-523	(vlzloldgrt) = ifugxuiqza wrmdgigzbq (xdogucrkux, ktkgyebklv - tvnxiaosbq) View more	-	11 Nov 2021
NCT03454035 (ASCO2021)	Phase 1	HR-positive/HER2-low Solid Tumors	26	Ulixertinib 300mg BID + Palbociclib 75mg daily	(osbbtmvoko) = ashbebmtxt hvfvuziwkc (twpqmkfxig, 1.87 - notdetermined)	-	28 May 2021
NCT01781429 (Pubmed \| Invest New Drugs)	Phase 1	Advanced cancer	135	Ulixertinib	dluabjzedh(npofffgaft) = The most common dAEs included acneiform rash (45/135, 33%), maculopapular rash (36/135, 27%), and pruritus (34/135, 25%). Grade 3 dAEs were observed in 19% (25/135) of patients; no grade 4 or 5 dAEs were seen. ssmgglmzwe (xipkvqizef )	-	03 Jan 2021
NCT03417739 (ASCO2020)	Phase 2	Uveal Melanoma	25	Ulixertinib (BVD-523)	oagokcqxfi(msmhwzgfqw) = Grade 3 and 4 toxicities associated with therapy were consistent with BVD-523 and other ERK inhibitors and included LFT elevation, hyponatremia, pruritis, amylase elevation, anemia and rash. ltqfthemmk (emlrqofhvd )	Negative	25 May 2020

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