Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This is a randomised trial with multiple experimental arms. Experimental Arm 1a (relapsed/refractory Myelofibrosis) participants will receive 150mg of TL-895 orally twice daily (BID), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 2a (JAKi Intolerant Myelofibrosis) participants will receive 150mg of TL-895 orally twice daily (BID), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 2b (JAKi Intolerant Myelofibrosis) participants will receive 300mg of TL-895 orally once daily (QD), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 3a (JAKi Ineligible Myelofibrosis) participants will receive 150mg of TL-895 orally twice daily (BID), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 3b (JAKi Ineligible Myelofibrosis) participants will receive 300mg of TL-895 orally once daily (QD), continuously starting on Day 1 in a 28-day cycle. Experimental Arm 1 Expansion (Relapsed/Refractory Myelofibrosis) participants will receive TL-895 orally at RP2D and schedule. Experimental Arm 2 Expansion (JAKi Intolerant Myelofibrosis) will receive TL-895 orally at RP2D and schedule. Experimental Arm 3 Expansion (JAKi Ineligible Myelofibrosis) will receive TL-895 orally at RP2D and schedule.
Conditions
This trial is treating people with Myelofibrosis
Eligibility
Inclusion
- 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
- Prior treatment with any BTK or BMX 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
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have been diagnosed with cancer, but have not received any treatment.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Exclusion
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Telios Pharma, Inc.
Scientific 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
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