Trial record 1 of 1 for:
NCT05280509
Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05280509 |
|
Recruitment Status :
Recruiting
First Posted : March 15, 2022
Last Update Posted : February 21, 2023
|
Sponsor:
Telios Pharma, Inc.
Information provided by (Responsible Party):
Telios Pharma, Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myelofibrosis Primary Myelofibrosis Post-PV MF Post-ET Myelofibrosis | Drug: TL-895 Drug: Ruxolitinib | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 70 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Phase 1b - Dose Escalation Design Phase 2 - Dose Expansion |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | June 9, 2022 |
| Estimated Primary Completion Date : | October 2025 |
| Estimated Study Completion Date : | April 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Primary myelofibrosis
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Phase 1b - Dose Level 1
150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.
|
Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth. Drug: Ruxolitinib Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
Other Names:
|
|
Experimental: Phase 1b - Dose Level 2
300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.
|
Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth. Drug: Ruxolitinib Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
Other Names:
|
|
Experimental: Phase 1b - Dose Level 3
450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.
|
Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth. Drug: Ruxolitinib Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
Other Names:
|
|
Experimental: Phase 2 - Cohort 1 JAKi treatment-naïve MF
The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. The dose of ruxolitinib will be based on the subject's baseline platelet count. |
Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth. Drug: Ruxolitinib Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
Other Names:
|
|
Experimental: Phase 2 - Cohort 2 suboptimal response to Ruxolitinib
The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. The dose schedule will be the stable ruxolitinib dose schedule as the subject is currently taking prior to entry into the study. |
Drug: TL-895
TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth. Drug: Ruxolitinib Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.
Other Names:
|
Primary Outcome Measures :
- Phase 1b - Recommended Phase 2 dose of TL-895 in combination with ruxolitinib [ Time Frame: 28 days ]Dose-limiting toxicities (DLTs) will be used to establish the maximum-tolerated dose (MTD) of TL-895 in combination with ruxolitinib. The safety review committee (SRC) will determine the RP2D based on safety and efficacy data of the combination of TL-895 and ruxolitinib.
- Phase 2 - Spleen Volume Reduction (SVR) at Week 24 [ Time Frame: 24 Weeks ]The proportion of subjects achieving SVR of ≥35% at Week 24 by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
Secondary Outcome Measures :
- Phase 1b - Spleen Volume Reduction (SVR) at Week 24 [ Time Frame: 24 Weeks ]The proportion of subjects achieving ≥35% SVR at Week 24 by MRI or CT scan.
- Phase 1b - TSS reduction at Week 24 [ Time Frame: 24 Weeks ]The proportion of subjects achieving ≥50% reduction in TSS at Week 24 by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
- Phase 2 - TSS reduction at Week 24 [ Time Frame: 24 Weeks ]The proportion of subjects achieving ≥50% reduction in TSS at Week 24 by MFSAF v4.0.
- DOR Spleen [ Time Frame: 48 Months ]Time from initial SVR of ≥ 35% by MRI/CT until the first occurrence of disease progression or death
- Progression Free Survival [ Time Frame: 48 Month ]Time from first dose to progression or death from any cause.
- Overall Survival [ Time Frame: 48 Months ]Time from first dose to death from any cause
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05280509
Contacts
| Contact: John Mei | 650-542-0136 | jmei@teliospharma.com | |
| Contact: Nikki Stuart | nzona@teliospharma.com |
Locations
Show 19 study locations
Sponsors and Collaborators
Telios Pharma, Inc.
| Responsible Party: | Telios Pharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT05280509 |
| Other Study ID Numbers: |
TL-895-209 |
| First Posted: | March 15, 2022 Key Record Dates |
| Last Update Posted: | February 21, 2023 |
| Last Verified: | February 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Telios Pharma, Inc.:
|
Myelofibrosis |
Additional relevant MeSH terms:
|
Primary Myelofibrosis Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |