Description:
This study evaluates TL-895, a potent, orally-available and highly selective irreversible
tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must be
relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive
JAKi treatment.
Title
- Brief Title: Study of TL-895 in Subjects With Myelofibrosis
- Official Title: A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis
Clinical Trial IDs
- ORG STUDY ID:
TL-895-201
- NCT ID:
NCT04655118
Conditions
Interventions
Drug | Synonyms | Arms |
---|
TL-895 | | Arm 1 Expansion, Relapsed/Refractory Myelofibrosis |
Purpose
This study evaluates TL-895, a potent, orally-available and highly selective irreversible
tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must be
relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive
JAKi treatment.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1a, Relapsed/Refractory Myelofibrosis | Experimental | 150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. | |
Arm 1b, Relapsed/Refractory Myelofibrosis | Experimental | 300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle. | |
Arm 2a, JAKi Intolerant Myelofibrosis | Experimental | 150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. | |
Arm 2b, JAKi Intolerant Myelofibrosis | Experimental | 300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle. | |
Arm 3a, JAKi Ineligible Myelofibrosis | Experimental | 150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. | |
Arm 3b, JAKi Ineligible Myelofibrosis | Experimental | 300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle. | |
Arm 1 Expansion, Relapsed/Refractory Myelofibrosis | Experimental | TL-895 administered orally at RP2D and schedule | |
Arm 2 Expansion, JAKi Intolerant Myelofibrosis | Experimental | TL-895 administered orally at RP2D and schedule | |
Arm 3 Expansion, JAKi Ineligible Myelofibrosis | Experimental | TL-895 administered orally at RP2D and schedule | |
Eligibility Criteria
Inclusion Criteria:
- Adults ≥18 years of age
- Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating
physician according to the World Health Organization (WHO) criteria
- Palpable spleen measuring ≥5 cm below the LLCM or spleen volume of ≥450 cm3 by MRI or
CT scan assessment
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- Adequate hematologic, hepatic, and renal functions
Exclusion Criteria:
- Prior treatment with any BCR-ABL, phosphoinositide 3-kinase (PI3K), mammalian target
of rapamycin (mTOR), bromodomain and extraterminal domain (BET) or spleen tyrosine
kinase (Syk) inhibitors
- Cohorts 1 and 2 - Prior treatment with JAKi within 21 days of the Screening MRI/CT
scan. Subjects in Cohort 3 must not have received JAKi
- Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study
treatment
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Primary Objective, Part A: To determine the RP2D of TL-895 in each cohort. |
Time Frame: | 9 months |
Safety Issue: | |
Description: | The safety review committee (SRC) will determine the RP2D for Cohorts 1, 2 and 3 based on safety and tolerability data obtained from each arm of that cohort. |
Secondary Outcome Measures
Measure: | Key Secondary Objective: Improvement in Total Symptom Score at Week 24. |
Time Frame: | Week 24 |
Safety Issue: | |
Description: | The proportion of subjects achieving ≥50% reduction in Total Symptom Score at Week 24 by MFSAF v4.0. |
Measure: | Key Secondary Objective: To determine the duration of response (DOR). |
Time Frame: | 44 months |
Safety Issue: | |
Description: | Time from initial response to progression. |
Measure: | Key Secondary Objective: To determine the progression-free survival (PFS). |
Time Frame: | 44 months |
Safety Issue: | |
Description: | Time from the first dose to progression or death from any cause. |
Measure: | Key Secondary Objective: To determine the duration overall response (OS). |
Time Frame: | 44 months |
Safety Issue: | |
Description: | Time from the first dose to death of any cause. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Telios Pharma, Inc. |
Last Updated
August 5, 2021