Navtemadlin

DRUG9 trials

Sponsors

Telios Pharma, Inc., National Cancer Institute (NCI), Kartos Therapeutics, Inc.

Conditions

Acute Myeloid LeukemiaAcute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeChronic Lymphocytic LeukemiaEndometrial CancerGlioblastomaGliosarcomaMFMGMT-Unmethylated Glioblastoma

Phase 1

Phase I/II, FIH, Dose Escalation Trial of TL-895 and Expansion of TL-895 Monotherapy and Combination Therapy With Navtemadlin in Tx-Naïve and R/R CLL/SLL Subjects

Telios Pharma, Inc.Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma and Diffuse Large B Cell Lymphoma, Relapsed/Refractory B Cell Malignancies +2

Start: 2016-08-26End: 2025-12-01Target: 130Updated: 2023-07-13

Testing the Addition of KRT-232 (AMG 232) to Usual Chemotherapy for Relapsed Multiple Myeloma

TerminatedNCT03031730

National Cancer Institute (NCI)Plasmacytoma, Recurrent Multiple Myeloma, Refractory Multiple Myeloma

Start: 2018-06-14End: 2024-07-24Updated: 2026-02-10

Testing a New Chemotherapy Drug, KRT-232 (AMG-232) in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia

Active, not recruitingNCT03041688

National Cancer Institute (NCI)Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia +1

Start: 2018-02-08End: 2026-06-30Target: 58Updated: 2026-04-03

Testing the Ability of AMG 232 (KRT 232) to Get Into the Tumor in Patients With Brain Cancer

TerminatedNCT03107780

National Cancer Institute (NCI)Glioblastoma, Gliosarcoma, MGMT-Unmethylated Glioblastoma +1

Start: 2018-07-09End: 2025-08-15Updated: 2025-11-13

Navtemadlin and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma

CompletedNCT03217266

National Cancer Institute (NCI)Resectable Soft Tissue Sarcoma, Soft Tissue Sarcoma

Start: 2018-06-20End: 2025-09-04Updated: 2025-09-23

Testing the Addition of an Anti-cancer Drug, Navtemadlin, to the Usual Treatments (Cytarabine and Idarubicin) in Patients With Acute Myeloid Leukemia

Active, not recruitingNCT04190550

National Cancer Institute (NCI)Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome

Start: 2021-02-04End: 2026-06-30Target: 24Updated: 2026-04-03

Study of Navtemadlin Plus Pembrolizumab as Maintenance Therapy in Locally Advanced and Metastatic Non-Small Cell Lung Cancer

WithdrawnNCT05705466

Kartos Therapeutics, Inc.Non Small Cell Lung Cancer

Start: 2023-06-30End: 2027-06-30Updated: 2024-03-22

Phase 2

Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer

RecruitingNCT05797831

Kartos Therapeutics, Inc.Endometrial Cancer

Start: 2023-07-17End: 2027-07-31Target: 268Updated: 2024-05-02

Phase 3

Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

RecruitingNCT06479135

Kartos Therapeutics, Inc.MF, Myelofibrosis, Post-ET Myelofibrosis +2

Start: 2024-06-03End: 2028-12-31Target: 600Updated: 2025-09-25

Related Papers

POIESIS: a phase III study of add-on navtemadlin in JAK inhibitor-naïve myelofibrosis patients with a suboptimal response to ruxolitinib.

2026-03-07

A window-of-opportunity trial reveals mechanisms of response and resistance to navtemadlin in patients with recurrent glioblastoma

Science Translational Medicine2025-02-198 citations

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

POIESIS: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Phase 3 Study of Navtemadlin As Add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Blood2024-11-053 citations

A Phase (Ph) 2 Study of TL-895, a Highly Selective, Novel Covalent BTK Inhibitor (BTKi), in Patients (pts) with Treatment-Naïve (TN) and Relapsed/Refractory (R/R) BTKi-Naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Blood2023-11-023 citations

TL-895, a Highly Selective, Covalent Inhibitor of Bruton's Tyrosine Kinase (BTK), Sensitizes Myeloproliferative Neoplasm (MPN)-Blast Phase Stem Cells to Navtemadlin By Targeting Intrinsic Dysregulated MDM2/p53 and NF-Κb Pathways and Disrupting the Protective Tumor Microenvironment (TME)

Blood2023-11-021 citations

TP008/#1500 Trial in progress: phase 2/3 study of navtemadlin as maintenance therapy in patients with advanced or recurrent endometrial cancer who responded to chemotherapy (ENGOT-EN21; GOG-3089)

2023-11-01

#84 Trial in progress: a phase 2/3 study of navtemadlin as maintenance therapy in patients with advanced or recurrent endometrial cancer (EC) who responded to chemotherapy (ENGOT-En21 and GOG-3089)

2023-09-01

P1006: CHARACTERIZATION OF TL-895: A NOVEL BRUTON TYROSINE KINASE INHIBITOR (BTKI) IN CLINICAL DEVELOPMENT FOR CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND MYELOFIBROSIS (MF)

HemaSphere2023-08-011 citations

NRG-DT001 phase Ib trial of neoadjuvant navtemadlin (previously AMG232 and KRT232) concurrent with preoperative radiotherapy in wild-type p53 soft tissue sarcoma of the extremity and body wall.

Journal of Clinical Oncology2022-06-012 citations

Phase I, first-in-human trial of Bruton’s tyrosine kinase inhibitor M7583 in patients with B-cell malignancies

Leukemia & lymphoma/Leukemia and lymphoma2021-04-245 citations

MDM2 inhibitor AMG-232 and radiation therapy in treating patients with soft tissue sarcoma with wild-type TP53: A phase IB study (NRG-DT001).

Journal of Clinical Oncology2019-05-209 citations

A Phase I/II, First in Human Trial of the Bruton's Tyrosine Kinase Inhibitor M7583 in Patients with B-Cell Malignancies

Blood2018-11-293 citations

Phase I/II, first in human trial with M7583, a Bruton’s tyrosine kinase inhibitor (BTKi), in patients with B cell malignancies

Annals of Oncology2018-10-013 citations

First in Human, Phase I/II Trial of the Bruton's Tyrosine Kinase Inhibitor (BTKi) M7583 in Patients with B Cell Malignancies: Study Design and Initial Outcomes

Blood2017-12-073 citations

Phase I/II, first in human trial of the Bruton’s tyrosine kinase inhibitor (BTKi) M7583 in patients with B cell malignancies.

Journal of Clinical Oncology2017-05-202 citations