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

Kartos Therapeutics, Inc.52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Myelofibrosis (PMF)Post-Polycythemia Vera Myelofibrosis (Post-PV-MF)Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)

Interventions

KRT-232DRUG

KRT-232, administration by mouth

TL-895DRUG

TL-895, administration by mouth

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (29)

Outcomes

Primary Outcomes

Spleen Volume Reduction (SVR)

The proportion of subjects achieving ≥35% SVR at Week 24 by MRI/CT (central review)

Time frame: 24 weeks

Secondary Outcomes

Improvement in Total Symptom Score (TSS)

The proportion of subjects who have at least a 50% reduction from Baseline to Week 24 in the total symptom score as measured by the MF-SAF v4.0

Time frame: 24 weeks

Spleen Response Duration

Time from initial SVR of ≥35% by MRI/CT (central review) until progression

Time frame: 48 months

Rate of conversion from RBC transfusion dependent to independent

The proportion of subjects who convert from transfusion dependent to transfusion independent at Week 24

Time frame: 24 weeks

Overall Survival (OS)

Time from first dose to death from any cause

Time frame: 48 months

Progression free survival (PFS)

Time from randomization to either first occurrence of disease progression or death due to any cause

Time frame: 48 months

Central Contacts

John Mei

CONTACT

650-542-0136 jmei@kartosthera.com

Jordan Blevins

CONTACT

650-542-0136 jblevins@kartosthera.com

Data from ClinicalTrials.gov

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