zilurgisertib (INCB00928) / Incyte 
Welcome,         Profile    Billing    Logout  
  Diseases    Trials    Trials    News 
  • ||||||||||  MODULE 4: Future Directions in the Management of MF (Manchester Grand Hyatt San Diego, Seaport Ballroom EFGH; In-Person; Virtual) -  Oct 5, 2024 - Abstract #ASH2024ASH_130;    
    Study results support further clinical development of zilurgisertib in patients. This program is supported by educational grants from CTI BioPharma, a Sobi Company, Geron Corporation, GSK, Incyte Corporation and Karyopharm Therapeutics.Mechanism of antitumor activity of navitoclax and biological rationale for its evaluation for MF Available efficacy and safety findings from the Phase III TRANSFORM-1 study of navitoclax in combination with ruxolitinib versus ruxolitinib alone for patients with previously untreated MF Potential role of navitoclax in the up-front setting and ongoing evaluation for relapsed/refractory (R/R) disease in the Phase III TRANSFORM-2 study Rationale for the evaluation of BET inhibitors for MF; updated findings from the Phase III MANIFEST-2 study combining pelabresib to ruxolitinib for JAK inhibitor-na
  • ||||||||||  zilurgisertib (INCB00928) / Incyte
    Trial completion:  INCB 00928-105: To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma (clinicaltrials.gov) -  Aug 28, 2024   
    P1/2,  N=22, Completed, 
    This program is supported by educational grants from CTI BioPharma, a Sobi Company, Geron Corporation, GSK, Incyte Corporation and Karyopharm Therapeutics.Mechanism of antitumor activity of navitoclax and biological rationale for its evaluation for MF Available efficacy and safety findings from the Phase III TRANSFORM-1 study of navitoclax in combination with ruxolitinib versus ruxolitinib alone for patients with previously untreated MF Potential role of navitoclax in the up-front setting and ongoing evaluation for relapsed/refractory (R/R) disease in the Phase III TRANSFORM-2 study Rationale for the evaluation of BET inhibitors for MF; updated findings from the Phase III MANIFEST-2 study combining pelabresib to ruxolitinib for JAK inhibitor-na Active, not recruiting --> Completed
  • ||||||||||  Review, Journal:  ACVR1: A Novel Therapeutic Target to Treat Anemia in Myelofibrosis. (Pubmed Central) -  Jan 11, 2024   
    Luspatercept (ACVR2B ligand trap) is assessed in transfusion-dependent MF patients in a registrational phase 3 trial. Approved ACVR1 inhibitors and novel agents in development are poised to improve the outcomes of anemic MF patients.
  • ||||||||||  MODULE 3: Future Directions in the Management of MF (LEVEL 3, MEAL THEATER 1; Virtual) -  Aug 11, 2023 - Abstract #SOHO2023SOHO_338;    
    This activity is supported through independent medical education grants from Bristol Myers Squibb, CTI Biopharma Corp, and GlaxoSmithKline. Mechanism of antitumor activity of navitoclax and biological rationale for its evaluation in patients with MF, Published research with navitoclax alone and in combination with ruxolitinib for MF; ongoing Phase III studies, Rationale for the inhibition of BET proteins in patients with MF; mechanisms of action of pelabresib and BMS-986158, Early clinical trial findings and ongoing research with BET inhibitors as monotherapy and in combination with JAK2 inhibitors for MF, Mechanism of action of, available data with and ongoing evaluation of luspatercept as monotherapy or combined with a JAK2 inhibitor for patients with MF and anemia; current role, if any, Published activity and safety data with and ongoing investigation of other novel agents and strategies (eg, bomedemstat, zilurgisertib, selinexor, navtemadlin) in MF,
  • ||||||||||  momelotinib (GSK3070785) / GSK, Vonjo (pacritinib) / SOBI, zilurgisertib (INCB00928) / Incyte
    Addressing Anemia in Myelofibrosis (LEVEL 3, GENERAL ASSEMBLY) -  Jun 21, 2023 - Abstract #SOHO2023SOHO_146;    
    Additional agents selectively targeting ACVR1/ ALK2 (e.g., INCB000928) are currently under investigation in MF. Preclinical and clinical data with these agents, as well as other modalities to address anemia in MF, will be covered in this presentation.
  • ||||||||||  Jakafi (ruxolitinib) / Incyte, zilurgisertib (INCB00928) / Incyte
    Trial completion date, Trial primary completion date, Combination therapy, Monotherapy:  LIMBER: INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders (clinicaltrials.gov) -  Nov 7, 2022   
    P1/2,  N=100, Recruiting, 
    Blank dialysate and phosphate-buffered saline were determined to be appropriate surrogate matrices by using a three-way cross-comparison and were subsequently validated in the quantitative analysis of INCB000928 in hemodialysate. Trial completion date: Oct 2023 --> Apr 2024 | Trial primary completion date: Sep 2023 --> Apr 2024
  • ||||||||||  INCB00928 / Incyte
    Journal:  Bioanalysis of INCB000928 in human saliva: nonspecific binding and inhomogeneous concentration. (Pubmed Central) -  Apr 5, 2022   
    Incurred sample reanalysis (ISR) using a successfully validated method failed in a healthy volunteer study because of inhomogeneous INCB000928 concentration across sample tube depths. Individual mixing of sample tubes followed by immediate aliquoting corrected the ISR failure, with 97.2% of repeats passing versus 41.7% for the same ISR samples.
  • ||||||||||  Darzalex IV (daratumumab) / J&J, INCB00928 / Incyte
    A Phase 1/2, Open-Label, Multicenter Study of INCB000928 Monotherapy in Patients with Anemia Due to Myelodysplastic Syndromes or Multiple Myeloma (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_5400;    
    P1/2
    Key exclusion criteria include presence of MDS with ring sideroblasts or with atypical chronic myeloid leukemia, juvenile myelomonocytic leukemia, or MDS/MPN overlap syndromes with ring sideroblasts and thrombocytosis; MDS requiring cytoreductive treatment other than hydroxyurea; MDS with bone marrow and peripheral blood myeloblast count ≥10%; platelet count <50×10 9 /L; or is a candidate for or has had prior allogeneic stem cell transplantation...Patients will receive treatment for up to 6 months and may continue if deriving clinical benefit and no progression occurs. Sites are open in the United States, France, and Italy.
  • ||||||||||  Darzalex IV (daratumumab) / J&J, INCB000928 / Incyte
    [VIRTUAL] A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY OF INCB000928 MONOTHERAPY IN PATIENTS WITH ANEMIA DUE TO MYELODYSPLASTIC SYNDROMES OR MULTIPLE MYELOMA () -  May 13, 2021 - Abstract #EHA2021EHA_1640;    
    P1/2
    Key exclusion criteria are: presence of MDS with ring sideroblasts or with atypical chronic myeloid leukemia, juvenile myelomonocytic leukemia, or MDS/MPN overlap syndromes with ring sideroblasts and thrombocytosis; MDS requiring cytoreductive treatment other than hydroxyurea; MDS with bone marrow and peripheral blood myeloblast count ≥10%; platelet count <50 × 109/L; or prior allogeneic stem cell transplantation...Sites are opening in the United States, France, and Italy. Results Not applicable Conclusion Not applicable
  • ||||||||||  Jakafi oral (ruxolitinib) / Novartis, Incyte, INCB000928 / Incyte
    [VIRTUAL] A Phase 1/2 Study of INCB000928 as Monotherapy or in Combination with Ruxolitinib in Patients with Anemia Due to Myelofibrosis (INCB 00928-104) () -  May 12, 2021 - Abstract #BSH2021BSH_329;    
    P1/2
    Primary objective is to determine the safety and tolerability of INCB000928 as monotherapy or combined with ruxolitinib. Second- ary objectives are to determine the efficacy of INCB000928 as monotherapy or combined with ruxolitinib (anemia response, dura- tion of anemia response, mean change from baseline in hemoglobin, and RBC transfusion rate through weeks 24 and 48); evaluate INCB000928 pharmacokinetics; and evaluate effects of INCB000928 as monotherapy or combined with ruxolitinib on hepcidin levels and other measures of iron homeostasis and erythropoiesis.
  • ||||||||||  zilurgisertib (INCB00928) / Incyte
    Enrollment open, Trial completion date, Monotherapy:  INCB 00928-105: To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma (clinicaltrials.gov) -  Apr 8, 2021   
    P1/2,  N=80, Recruiting, 
    Second- ary objectives are to determine the efficacy of INCB000928 as monotherapy or combined with ruxolitinib (anemia response, dura- tion of anemia response, mean change from baseline in hemoglobin, and RBC transfusion rate through weeks 24 and 48); evaluate INCB000928 pharmacokinetics; and evaluate effects of INCB000928 as monotherapy or combined with ruxolitinib on hepcidin levels and other measures of iron homeostasis and erythropoiesis. Not yet recruiting --> Recruiting | Trial completion date: Jan 2023 --> Jul 2023
  • ||||||||||  Jakafi oral (ruxolitinib) / Novartis, Incyte, INCB000928 / Incyte
    [VIRTUAL] A Phase 1/2 Study of INCB000928 as Monotherapy or in Combination with Ruxolitinib in Patients with Anemia Due to Myelofibrosis (INCB 00928-104) () -  Mar 11, 2021 - Abstract #AACR2021AACR_3904;    
    P1/2
    Primary objective is to determine the safety and tolerability of INCB000928 as monotherapy or combined with ruxolitinib. Secondary objectives are to determine the efficacy of INCB000928 as monotherapy or combined with ruxolitinib (anemia response, duration of anemia response, mean change from baseline in hemoglobin, and RBC transfusion rate through weeks 24 and 48); evaluate INCB000928 pharmacokinetics; and evaluate effects of INCB000928 as monotherapy or combined with ruxolitinib on hepcidin levels and other measures of iron homeostasis and erythropoiesis.
  • ||||||||||  Jakafi (ruxolitinib) / Incyte, zilurgisertib (INCB00928) / Incyte
    Enrollment open, Combination therapy, Monotherapy:  LIMBER: INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders (clinicaltrials.gov) -  Jan 18, 2021   
    P1/2,  N=100, Recruiting, 
    Secondary objectives are to determine the efficacy of INCB000928 as monotherapy or combined with ruxolitinib (anemia response, duration of anemia response, mean change from baseline in hemoglobin, and RBC transfusion rate through weeks 24 and 48); evaluate INCB000928 pharmacokinetics; and evaluate effects of INCB000928 as monotherapy or combined with ruxolitinib on hepcidin levels and other measures of iron homeostasis and erythropoiesis. Not yet recruiting --> Recruiting
  • ||||||||||  INCB000928 / Incyte
    [VIRTUAL] Characterization of INCB00928, a Potent and Selective ALK2 Inhibitor for the Treatment of Anemia (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_3893;    
    For the majority of patients with MF, the management of anemia remains an unmet need. The preclinical findings from this study suggest ALK2 kinase inhibition with INCB00928 may be a promising novel treatment to reduce the production of hepcidin and improve MF-related anemia in humans, thus warranting further investigation.
  • ||||||||||  Jakafi oral (ruxolitinib) / Novartis, Incyte, INCB000928 / Incyte
    [VIRTUAL] A Phase 1/2 Study of INCB000928 As Monotherapy or in Combination with Ruxolitinib in Patients with Anemia Due to Myelofibrosis (INCB 00928-104) (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_3798;    
    P1/2
    The primary study objective is to determine the safety and tolerability of INCB000928 monotherapy or in combination with ruxolitinib, and to identify dose-limiting toxicities, MTD, and RDE for TGB). Secondary objectives are: to determine the efficacy of INCB000928 monotherapy or in combination with ruxolitinib (assessed by anemia response, duration of anemia response, mean change from baseline in hemoglobin, and rate of RBC transfusion through week 24 and 48); to evaluate pharmacokinetics of INCB000928; and to evaluate the effect of INCB000928 as monotherapy or in combination with ruxolitinib on hepcidin level, and other measures of iron homeostasis and erythropoiesis.