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
Sponsor: Kartos Therapeutics, Inc.
ClinicalTrials ID:NCT04485260
This Phase 1b/2 study evaluates the safety and efficacy of KRT-232 with ruxolitinib in MF patients with suboptimal ruxolitinib response. Eligible participants must have confirmed PMF, post-PV MF, or post-ET MF, stable ruxolitinib use, and specific spleen and symptom criteria. Exclusions include TP53 mutations and prior MDM2 inhibitor therapy. Both drugs are administered orally.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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.
Eligibility 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
Get This Program In Your Inbox
You can sign up and apply your patients for this program.