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Clinical trial

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With Ruxolitinib in Janus-associated Kinase Inhibitor (JAKi) Treatment-Naïve Myelofibrosis (MF) Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

ID
Name
TL-895-209
Description
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.
Trial arms
Trial start
2022-06-09
Estimated PCD
2025-10-01
Trial end
2027-04-01
Status
Recruiting
Phase
Early phase I
Treatment
TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
Arms:
Phase 1b - Dose Level 1, Phase 1b - Dose Level 2, Phase 1b - Dose Level 3, Phase 2 - Cohort 1 JAKi treatment-naïve MF, Phase 2 - Cohort 2 suboptimal response to Ruxolitinib
Ruxolitinib
Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
Arms:
Phase 1b - Dose Level 1, Phase 1b - Dose Level 2, Phase 1b - Dose Level 3, Phase 2 - Cohort 1 JAKi treatment-naïve MF, Phase 2 - Cohort 2 suboptimal response to Ruxolitinib
Other names:
Jakafi, Jakavi
Size
70
Primary endpoint
Phase 1b - Recommended Phase 2 dose of TL-895 in combination with ruxolitinib
28 days
Phase 2 - Spleen Volume Reduction (SVR) at Week 24
24 Weeks
Eligibility criteria
Inclusion Criteria: Subjects with suboptimal response to ruxolitinib: * Treatment with at a stable dose of ruxolitinib prior to study entry * Subjects ≥ 18 years of age and able to provide informed consent. * Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria * High-risk, intermediate-2 risk, or intermediate-1 risk, defined by Dynamic International Prognostic System (DIPSS) * Palpable spleen measuring ≥ 5 cm below the left lower coastal margin (LLCM) or spleen volume of ≥ 450 cm3 by MRI or CT scan assessment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Adequate hematological, hepatic, \& renal function. Exclusion Criteria: Treatment-naive subjects: * Prior treatment with any JAKi Subjects with suboptimal response to ruxolitinib: * Documented disease progression while on ruxolitinib treatment All subjects: * Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment * Prior treatment with a BTK or BMX inhibitor
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 1b - Dose Escalation Design Phase 2 - Dose Expansion', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}
Updated at
2023-02-21

1 organization

2 products

4 indications

Organization
Telios Pharma
Product
TL-895
Indication
Myelofibrosis
Indication
Primary Myelofibrosis
Indication
Post-Polycythemia Vera Myelofibrosis
Indication
Post-ET Myelofibrosis
Product
Ruxolitinib