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KRT-232

DRUG11 trials

Sponsors

Kartos Therapeutics, Inc., Telios Pharma, Inc.

Conditions

Acute Myeloid LeukemiaAcute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN)Chronic Lymphocytic LeukemiaChronic Myeloid LeukemiaDiffuse Large B Cell LymphomaMerkel Cell CarcinomaMyelofibrosisNon Hodgkin Lymphoma

Phase 1

Navtemadlin (KRT-232) With or Without Anti-PD-1/Anti-PD-L1 for the Treatment of Patients With Merkel Cell Carcinoma
NCT03787602
Kartos Therapeutics, Inc.Merkel Cell Carcinoma
Start: 2019-03-19End: 2025-08-31Target: 115Updated: 2023-03-02
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)
TerminatedNCT04113616
Kartos Therapeutics, Inc.Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN), Relapsed or Refractory Acute Myeloid Leukemia (AML)
Start: 2019-09-25End: 2023-09-27Updated: 2024-03-22
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post ET-MF) Who Have a Suboptimal Response to Ruxolitinib
NCT04485260
Kartos Therapeutics, Inc.Myelofibrosis
Start: 2021-01-28End: 2024-10-31Target: 36Updated: 2022-05-09
Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL
NCT04502394
Kartos Therapeutics, Inc.Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Non Hodgkin Lymphoma
Start: 2021-02-23End: 2024-03-31Target: 84Updated: 2022-08-04
KRT-232 in Combination With TL-895 for the Treatment of R/R MF and KRT-232 for the Treatment of JAKi Intolerant MF
NCT04640532
Kartos Therapeutics, Inc.Myelofibrosis, Post-ET Myelofibrosis, Post-PV MF +1
Start: 2020-11-17End: 2025-07-24Target: 116Updated: 2022-05-09
TL-895 and KRT-232 Study in Acute Myeloid Leukemia
NCT04669067
Telios Pharma, Inc.Acute Myeloid Leukemia
Start: 2021-03-31End: 2025-11-30Updated: 2023-02-17
KRT-232 and TKI Study in Chronic Myeloid Leukemia
RecruitingNCT04835584
Kartos Therapeutics, Inc.Chronic Myeloid Leukemia
Start: 2021-05-07End: 2026-06-30Target: 109Updated: 2022-03-21

Phase 2

KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment
NCT03662126
Kartos Therapeutics, Inc.Post-Essential Thrombocythemia MF (Post-ET-MF), Post-Polycythemia Vera MF (Post-PV-MF), Primary Myelofibrosis (PMF)
Start: 2019-01-15End: 2025-12-31Target: 385Updated: 2023-04-28
KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera
NCT03669965
Kartos Therapeutics, Inc.Polycythemia Vera
Start: 2019-01-15End: 2022-10-31Updated: 2020-07-31
Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
NCT04878003
Kartos Therapeutics, Inc.Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF), Primary Myelofibrosis (PMF)
Start: 2021-04-13End: 2025-10-31Target: 52Updated: 2022-05-09
KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
TerminatedNCT05027867
Kartos Therapeutics, Inc.Small-cell Lung Cancer, Small Cell Lung Cancer Extensive Stage, Small Cell Lung Cancer Recurrent +1
Start: 2021-12-06End: 2022-08-26Updated: 2023-08-16

Related Papers

Results from the Randomized, Multicenter, Global Phase 3 BOREAS Study: Navtemadlin Versus Best Available Therapy in JAK Inhibitor Relapsed<i>/</i>Refractory Myelofibrosis
Blood2024-11-058 citations
Disease-Modifying Activity of Navtemadlin Correlates with Clinical Responses in a Randomized, Multicenter, Global Phase 3 Study (BOREAS) in JAK-Inhibitor Relapsed/Refractory Myelofibrosis
Blood2024-11-055 citations
Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies
Blood2023-11-02
S210: AN OPEN-LABEL, GLOBAL, PHASE (PH) 1B/2 STUDY ADDING NAVTEMADLIN (NVTM) TO RUXOLITINIB (RUX) IN PATIENTS (PTS) WITH PRIMARY OR SECONDARY MYELOFIBROSIS (MF) WHO HAVE A SUBOPTIMAL RESPONSE TO RUX
HemaSphere2023-08-016 citations
S214: DISEASE-MODIFYING ACTIVITY OF NAVTEMADLIN (NVTM) CORRELATED WITH SURVIVAL OUTCOMES IN JANUS KINASE INHIBITOR (JAKI) RELAPSED OR REFRACTORY (R/R) MYELOFIBROSIS (MF) PATIENTS (PTS)
HemaSphere2023-08-013 citations
P1038: TL-895, A FIRST-IN-CLASS, COVALENT BRUTON TYROSINE KINASE INHIBITOR (BTKI) FOR THE TREATMENT OF MYELOFIBROSIS (MF) PATIENTS (PTS) WITH SEVERE THROMBOCYTOPENIA (PLATELETS (PLTS) &lt;50 K/UL)
HemaSphere2023-08-011 citations
P1005: EFFECT OF TL-895, A NOVEL BRUTON’S TYROSINE KINASE INHIBITOR (BTKI), ON ONCOGENIC JANUS KINASE 2-V617F (JAK2VF) SIGNALING
HemaSphere2023-08-01
P625: A PHASE 1B/2 STUDY OF NAVTEMADLIN COMBINED WITH ACALABRUTINIB IN BTK INHIBITOR NAÏVE PATIENTS WITH RELAPSED/REFRACTORY (R/R) CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
HemaSphere2023-08-01
NOTOS: A pivotal study of navtemadlin, a first-in-class mouse double minute 2 inhibitor (MDM2i), in patients (pts) with <i>TP53</i> wild-type (<i>TP53<sup>WT</sup>)</i> Merkel cell carcinoma (MCC) for whom anti PD-1/L1 therapy has failed.
Journal of Clinical Oncology2023-06-01
Elucidating the Mechanism of Action (MOA) of Navtemadlin, an MDM2 Inhibitor, and Its Synergy with Gilteritinib in Myeloid Malignancies
Blood2022-11-151 citations
Navtemadlin (KRT-232) activity after failure of anti-PD-1/L1 therapy in patients (pts) with <i>TP53<sup>WT</sup></i> Merkel cell carcinoma (MCC).
Journal of Clinical Oncology2022-06-0115 citations
An open-label, multicenter, phase 1b/2 study of navtemadlin (KRT-232) in patients with relapsed/refractory acute myeloid leukemia secondary to myeloproliferative neoplasms.
Journal of Clinical Oncology2022-06-014 citations
An open-label, multicenter, phase 2 study of the safety and efficacy of navtemadlin (KRT-232) in patients with <i>TP53</i> wild-type relapsed/refractory small cell lung cancer.
Journal of Clinical Oncology2022-06-011 citations
The MDM2 antagonist idasanutlin in patients with polycythemia vera: results from a single-arm phase 2 study
Blood Advances2021-12-2123 citations
Potential Disease-Modifying Activity of Navtemadlin (KRT-232), a First-in-Class MDM2 Inhibitor, Correlates with Clinical Benefits in Relapsed/Refractory Myelofibrosis (MF)
Blood2021-11-0520 citations
A Phase 1b/2 Study of Navtemadlin (KRT-232), a Murine Double Minute 2 Inhibitor, Combined with a BCR-ABL Tyrosine Kinase Inhibitor in Patients with Relapsed/Refractory, <i>TP53</i>WT, Ph+ Chronic Myeloid Leukemia
Blood2021-11-054 citations
BOREAS: A global phase 3 study of KRT-232, a first-in-class murine double minute 2 (MDM2) inhibitor in <i>TP53</i><sup>WT</sup> relapsed/refractory (R/R) myelofibrosis (MF).
Journal of Clinical Oncology2021-05-208 citations
An Open-Label, Global, Multicenter, Phase 1b/2 Study of KRT-232, a First-in-Class, Oral Small-Molecule Inhibitor of Murine Double Minute 2 (MDM2), Combined with Ruxolitinib in Patients Who Have Myelofibrosis and a Suboptimal Response to Ruxolitinib
Blood2020-11-057 citations
A Phase 1b-2 Study of KRT-232, a First-in-Class, Oral, Small Molecule Inhibitor of Murine Double Minute 2 (MDM2), in Combination with Acalabrutinib for the Treatment of Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Blood2020-11-053 citations
KRT-232, a first-in-class, murine double minute 2 inhibitor (MDM2i), for TP53 wild-type (p53<sup>WT</sup>) Merkel cell carcinoma (MCC) after anti–PD-1/L1 immunotherapy.
Journal of Clinical Oncology2020-05-208 citations

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