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

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1b/2 study of KRT-232 combined with ruxolitinib in subjects with MF who have a suboptimal response after at least 18 weeks of treatment with ruxolitinib. The primary objective of the study is to determine a recommended phase 2 dose (RP2D) of KRT 232 in combination with ruxolitinib.

• Phase: Phase 1/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, as assessed by treating physician according to the World Health Organization (WHO)

• Treatment with ruxolitinib for ≥18 weeks prior to study entry, and on a stable dose of ruxolitinib in the 8 weeks prior to study entry

• Spleen ≥5 cm palpable below the LLCM or ≥450 cm3 by MRI or CT

• Patients must have at least 2 symptoms with a score of at least 1 on the MFSAF v4.0

• ECOG performance status of 0 to 2

Exclusion Criteria:

• Patients who are positive for TP53 mutations

• Documented disease progression or clinical deterioration any time while on ruxolitinib treatment

• Patients who have had a documented spleen response to ruxolitinib.

• Prior splenectomy

• Prior MDM2 inhibitor therapy or p53-directed therapy