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

Kartos Therapeutics

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Myelofibrosis

Treatments

Drug: KRT-232

Drug: Ruxolitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT04485260

KRT-232-109

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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