Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF)

The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kartos Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)

• High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS)

• ECOG of 0 or 1

Exclusion Criteria:

• Subjects who are positive for p53 mutation (Arm 1)

• Prior MDM2 inhibitor therapy or p53-directed therapy (Arm 1)

• Prior treatment with any JAK inhibitor

• Prior splenectomy

• Splenic irradiation within 24 weeks prior to randomization

• Prior allogeneic stem-cell transplantation or plans for allogeneic stem-cell transplant

• History of major organ transplant

• Grade 2 or higher QTc prolongation

• Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization