Recruiting
Phase 2

KRT-232 & TL-895

Sponsor:

Kartos Therapeutics, Inc.

Code:

NCT04878003

Conditions

Primary Myelofibrosis (PMF)

Post-Polycythemia Vera Myelofibrosis (Post-PV-MF)

Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KRT-232

TL-895

Study Details

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.

Conditions

Primary Myelofibrosis (PMF)

Post-Polycythemia Vera Myelofibrosis (Post-PV-MF)

Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)

Study ID

NCT04878003

Start date

Apr 13, 2021

Status verified date

May, 2022

Completion date

Oct, 2025

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

52 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1

KRT-232 administered orally as 240 mg once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles

experimental: Arm 2

TL-895 administered orally as 150 mg twice daily continuously in 28-day cycles

Interventions

KRT-232

KRT-232, administration by mouth

TL-895

TL-895, administration by mouth

Primary outcome measure

  • Spleen Volume Reduction (SVR) [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

John Mei

650-542-0136jmei@kartosthera.com

Jordan Blevins

650-542-0136jblevins@kartosthera.com

Locations

Innovative Clinical Research Institute

Recruiting

Glendale, California, United States, 90603

Innovative Clinical Research Institute

Recruiting

Whittier, California, United States, 90603

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Kartos Therapeutics, Inc.

Last update posted

May 9, 2022

Last verified

May, 2022

Keywords

  • navtemadlin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kartos Therapeutics, Inc. on 2022-05-09.