Study of KRT-232 or TL-895 in Janus Associated Kinase Inh... | NCT04878003

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

NCT04878003

Sponsor

Kartos Therapeutics, Inc.

Status

Unknown status

Last Update Posted

May 9, 2022Actual

Enrollment

52Estimated

Phase

Phase 2

Conditions

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

Interventions

KRT-232
TL-895

Countries

United States
Belarus
Bulgaria
Georgia
Mexico
Poland
Russia
South Africa
Ukraine

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 13, 2021Actual

Primary Completion Date

May 2024Estimated

Completion Date

Oct 2025Estimated

First Submitted Date

May 4, 2021

First Submission Date that Met QC Criteria

May 4, 2021

First Posted Date

May 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2022

Last Update Posted Date

May 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	KRT-232 administered orally as 240 mg once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles	Drug: KRT-232
Arm 2	Experimental	TL-895 administered orally as 150 mg twice daily continuously in 28-day cycles	Drug: TL-895

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KRT-232	Drug	KRT-232, administration by mouth	Arm 1
TL-895

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spleen Volume Reduction (SVR)	The proportion of subjects achieving ≥35% SVR at Week 24 by MRI/CT (central review)	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
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	24 weeks
Spleen Response Duration

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
John Mei	Contact	650-542-0136		jmei@kartosthera.com
Jordan Blevins	Contact	650-542-0136		jblevins@kartosthera.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Innovative Clinical Research Institute	Recruiting	Glendale	California	90603	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D009196	Myeloproliferative Disorders
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases