Clinical Trial Details
Back to clinical trials
Phase IIInterventional
A Phase 2 Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis, Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis, or Indolent Systemic Mastocytosis
Protocol: STUDY00009065NCT: NCT04655118
Overview
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.
Eligibility
| Ages | 18 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
Cohorts 1-3
Key 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
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- Adequate hematologic, hepatic, and renal functions
- MF symptoms as defined by having at least 2 symptoms with an average baseline (Day -7 to Day -1) score of at least 1 for each of the 2 symptoms per MFSAF v4.0
- Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of ≥ 25 and < 50 x 10^9/L
Key Exclusion Criteria:
- Prior treatment with any BTK or BMX inhibitors
- Prior treatment with JAKi within 28 days prior to study treatment
- Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
Cohort 5
Key Inclusion Criteria:
- Adults ≥18 years of age
- Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow biopsy pathology report results
- Subject must have moderate-to-severe symptoms
Key Exclusion Criteria:
- Prior treatment with any BTK or BMX inhibitors
- Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib
- Diagnosis with another myeloproliferative disorder
