Our Clinical Research

Navtemadlin (KRT-232) Development
Kartos Science Pipeline 20240229
Kartos-sponsored Trials

Myelofibrosis (MF) - POIESIS

Status: Recruiting

ClinicalTrials.gov: NCT06479135

Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Myelofibrosis (MF)

Status: Active, Not Recruiting

ClinicalTrials.gov: NCT04485260

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of Navtemadlin (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.

Myelofibrosis (MF) - BOREAS

Status: Active, Not Recruiting

ClinicalTrials.gov: NCT03662126

Navtemadlin (KRT-232) Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment (BOREAS)

Myelofibrosis (MF)

Status: Active, Not Recruiting

ClinicalTrials.gov: NCT04878003

An Open-Label, Multicenter, Phase 2 Study Assessing the Safety and Efficacy of Navtemadlin (KRT-232) in Janus-associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

Endometrial Cancer

Status: Recruiting

ClinicalTrials.gov: NCT05797831

A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy

NCI CTEP–sponsored Trials

Acute Myeloid Leukemia (AML)

Status: Recruiting

ClinicalTrials.gov: NCT03041688

A Phase 1B Study of KRT-232 (AMG 232) in Combination With Decitabine in Acute Myeloid Leukemia.

Glioblastoma

Status: Recruiting

ClinicalTrials.gov: NCT03107780

Phase 0/I Study of KRT-232 (AMG 232) Concentrations in Brain Tissue in Patients With Recurrent Glioblastoma and of AMG 232 (KRT 232) in Combination With Radiation in Patients With Newly Diagnosed Glioblastoma and Unmethylated MGMT Promoters.

Multiple Myeloma

Status: Recruiting

ClinicalTrials.gov: NCT03031730

A Phase 1 Dose-Escalation and Exploratory Dose Expansion Study of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomide, and Dexamethasone in Relapsed and/or Refractory Myeloma.

Soft Tissue Sarcoma (STS)

Status: Active, Not Recruiting

ClinicalTrials.gov: NCT03217266

A Phase Ib Trial of Neoadjuvant KRT-232 (AMG 232) Concurrent With Preoperative Radiotherapy in Wild-Type p53 Soft Tissue Sarcoma (STS)

Expanded Access Program

Expanded access, also known as “compassionate use,” refers to the use of an investigational agent outside of a clinical trial. This is a U.S. Food and Drug Administration (FDA) initiative that allows patients with serious illnesses, who have exhausted all other treatment options, the opportunity to access investigational agents that are not yet approved. It is important to remember that the safety and efficacy of these agents have not yet been established. Physicians and patients should discuss all possible benefits and risks before seeking expanded access to an investigational agent.

Kartos Therapeutics will evaluate each request for expanded access to KRT-232. All requests must be submitted to eap@kartosthera.com by a licensed healthcare professional. We will review the request promptly and respond within 48 hours.

For more information on the FDA Expanded Access program, please see the FDA website on Expanded Access, and/or talk to your healthcare provider.