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Closed (no longer recruiting)Last updated: 9 January 2024

This phase II trial is trying to determine the effectiveness and dosing level of a targeted therapy drug (TL-895) in people with MyelofibrosisA 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 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 patients with Myelofibrosis.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

More information

Trial Identifiers

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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

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 are able to swallow medication by mouth.
  • 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 have had treatment, but your cancer has come back.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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