Recruiting
Phase 1
Phase 2

KRT-232 & Ruxolitinib

Sponsor:

Kartos Therapeutics, Inc.

Code:

NCT04485260

Conditions

Myelofibrosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

KRT-232

Ruxolitinib

Study Details

Brief summary:

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.

Conditions

Myelofibrosis

Study ID

NCT04485260

Start date

Jan 28, 2021

Status verified date

May, 2022

Completion date

Oct, 2024

Anticipated

Primary completion date

Oct, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A, Arm 1, Cohort 1

KRT-232 by mouth once daily for Days 1-7, off treatment for Days 8-28 (28 day cycle)

Interventions

KRT-232

administered by mouth

Ruxolitinib

administered by mouth

Primary outcome measure

  • For Phase 1: To determine the KRT-232 RP2D in combination with ruxolitinib [ Time Frame: 15 months ]
  • For Phase 2:To determine the spleen volume reduction (SVR) at Week 24 [ Time Frame: 6 months after last patient enrolled ]

Central Contacts and Locations

Central contacts

John Mei

650-542-0136jmei@kartosthera.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

John Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44106

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109

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 2026-09-08. This information was provided to ClinicalTrials.gov by Kartos Therapeutics, Inc. on 2022-05-09.