Recruiting
Phase 1
Phase 2

KRT-232 & TL-895

Sponsor:

Kartos Therapeutics, Inc.

Code:

NCT04640532

Conditions

Myelofibrosis

Post-PV MF

Post-ET Myelofibrosis

Primary Myelofibrosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KRT-232

TL-895

Study Details

Brief summary:

This study evaluates KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis.

Conditions

Myelofibrosis

Post-PV MF

Post-ET Myelofibrosis

Primary Myelofibrosis

Study ID

NCT04640532

Start date

Nov 17, 2020

Status verified date

May, 2022

Completion date

Jul 24, 2025

Anticipated

Primary completion date

May 11, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Confirmed diagnosis of primary MF, post-PV MF, or post-ET MF, (WHO 2016)
  • ECOG ≤ 2
  • Cohort 1 and Cohort 2: R/R following JAK inhibitor treatment
  • Cohort 3: patients who are intolerant to JAK inhibitor treatment

Exclusion Criteria:

  • Prior treatment with MDM2 inhibitors or p53-directed therapies
  • Prior treatment with a BCR-ABL, phosphoinositide 3-kinase (PI3k), mammalian target of rapamycin (mTOR), bromodomain and extraterminal domain (BET), histone deacetylase (HDAC), or spleen tyrosine kinase (Syk) inhibitor
  • Prior splenectomy
  • Splenic irradiation within 3 months prior to the first dose of study treatment
  • Clinically significant thrombosis within 3 months of screening
  • Grade 2 or higher QTc prolongation

Study Design

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1 (R/R MF), Dose Level 1

TL-895 at 200 mg once a day (QD) continuously starting on Cycle 1 Day 1 in a 28-day cycle.

KRT-232 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle starting on Cycle 2 Day 1.

experimental: Cohort 1 (R/R MF), Dose Level 2

TL-895 at 300 mg once a day (QD) continuously starting on Cycle 1 Day 1 in a 28-day cycle.

KRT-232 at 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle starting on Cycle 2 Day 1.

experimental: Cohort 2 (R/R MF), Dose Level 1

TL-895 at 100 mg twice a day (BID) continuously starting on Cycle 1 Day 1 in a 28-day cycle.

KRT-232 at 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle starting on Cycle 2 Day 1.

experimental: Cohort 2 (R/R MF), Dose Level 2

TL-895 at 150 mg twice a day (BID) continuously starting on Cycle 1 Day 1 in a 28-day cycle.

KRT-232 at 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle starting on Cycle 2 Day 1.

experimental: Cohort 3 (JAKi Intolerant MF)

KRT-232 at 240mg will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle.

Interventions

KRT-232

KRT-232, administered by mouth

TL-895

TL-895, administered by mouth

Primary outcome measure

  • Phase 1b - The MTD/MAD and RP2D of TL-895 in combination with KRT-232 in patients with R/R MF (Cohort 1 and Cohort 2) [ Time Frame: 56 Days ]
  • Phase 2 - Spleen response rate for each cohort [ Time Frame: 24 Weeks ]

Central Contacts and Locations

Central contacts

John Mei

650-542-0136jmei@kartosthera.com

Irene Dea

(650) 839-7341idea@kartosthera.com

Locations

University of Alabama at Birmingham School of Medicine, Division of Hematology and Oncology

Recruiting

Birmingham, Alabama, United States, 35233

The Oncology Institute of Hope

Recruiting

Whittier, California, United States, 90603

Lake City Cancer Center

Recruiting

Lake City, Florida, United States, 32024

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Columbia University Medical Center

Recruiting

Fort Lee, New Jersey, United States, 07024

Memorial Sloan Kettering Cancer Center (MSKCC)

Recruiting

New York, New York, United States, 10065

More Information

Sponsor

Kartos Therapeutics, Inc.

Last update posted

May 9, 2022

Last verified

May, 2022

Keywords

  • Relapsed/Refractory Myelofibrosis
  • Janus associated Kinase Inhibitor-Intolerant Myelofibrosis
  • MDM2
  • 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.