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

An Open-Label, Multicenter, Phase 2 Study Assessing the Safety and Efficacy of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

Sponsors

Lead Sponsor: Kartos Therapeutics, Inc.

Source Kartos Therapeutics, Inc.
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.

Overall Status Recruiting
Start Date 2021-04-13
Completion Date 2025-10-01
Primary Completion Date 2024-05-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Spleen Volume Reduction (SVR) 24 weeks
Secondary Outcome
Measure Time Frame
Improvement in Total Symptom Score (TSS) 24 weeks
Spleen Response Duration 48 months
Rate of conversion from RBC transfusion dependent to independent 24 weeks
Overall Survival (OS) 48 months
Progression free survival (PFS) 48 months
Enrollment 52
Condition
Intervention

Intervention Type: Drug

Intervention Name: KRT-232

Description: KRT-232, administration by mouth

Arm Group Label: Arm 1

Intervention Type: Drug

Intervention Name: TL-895

Description: TL-895, administration by mouth

Arm Group Label: Arm 2

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: John Mei

Phone: 650-542-0136

Email: [email protected]

Location
Facility: Status:
Innovative Clinical Research Institute | Glendale, California, 90603, United States Recruiting
Innovative Clinical Research Institute | Whittier, California, 90603, United States Recruiting
Gabrail Cancer Center | Canton, Ohio, 44718, United States Recruiting
MD Anderson Cancer Center | Houston, Texas, 77030, United States Recruiting
UMHAT Georgi Stranski | Pleven, 5800, Bulgaria Recruiting
Medical Centre Hipokrat N | Plovdiv, 4000, Bulgaria Recruiting
UMHAT Sv. Ivan Rilski EAD | Sofia, 1431, Bulgaria Recruiting
Military Medical Academy | Sofia, 1606, Bulgaria Recruiting
Specialized Hospital for Active Treatment of Hematologic Diseases | Sofia, 1756, Bulgaria Recruiting
Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich | Katowice, 40-519, Poland Recruiting
Location Countries

Bulgaria

Poland

United States

Verification Date

2021-08-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm 1

Type: Experimental

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

Label: Arm 2

Type: Experimental

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

Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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