Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-06 @ 3:17 PM
Study NCT ID:
NCT04655118
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2020-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}, {'id': 'D034721', 'term': 'Mastocytosis, Systemic'}], 'ancestors': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008415', 'term': 'Mastocytosis'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000090362', 'term': 'Mast Cell Activation Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 121}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2020-11-24', 'studyFirstSubmitQcDate': '2020-12-03', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cohorts 1-3: Determine the RP2D of TL-895', 'timeFrame': '9 months', 'description': 'The RP2D for Cohorts 1, 2 and 3 will be reported'}, {'measure': 'Cohort 5: Determine the RP2D of TL-895', 'timeFrame': 'Week 24', 'description': 'The RP2D for Cohort 5 will be reported'}], 'secondaryOutcomes': [{'measure': 'Cohorts 1-3: Spleen volume reduction (SVR) rate', 'timeFrame': 'Week 24', 'description': 'The proportion of subjects achieving ≥35% SVR at Week 24 by MRI or CT scan (central review).'}, {'measure': 'Cohort 5: Changes in patient reported symptoms', 'timeFrame': 'Week 12', 'description': 'Mean change in patient reported symptom assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myelofibrosis', 'Indolent Systemic Mastocytosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Cohorts 1-3\n\nKey Inclusion Criteria:\n\n* Adults ≥18 years of age\n* Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2\n* Adequate hematologic, hepatic, and renal functions\n* 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\n* Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of ≥ 25 and \\< 50 x 10\\^9/L\n\nKey Exclusion Criteria:\n\n* Prior treatment with any BTK or BMX inhibitors\n* Prior treatment with JAKi within 28 days prior to study treatment\n* Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment\n\nCohort 5\n\nKey Inclusion Criteria:\n\n* Adults ≥18 years of age\n* Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow biopsy pathology report results\n* Subject must have moderate-to-severe symptoms\n\nKey Exclusion Criteria:\n\n* Prior treatment with any BTK or BMX inhibitors\n* Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib\n* Diagnosis with another myeloproliferative disorder'}, 'identificationModule': {'nctId': 'NCT04655118', 'briefTitle': 'Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Telios Pharma, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TL-895-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1a, Relapsed/Refractory Myelofibrosis', 'description': '150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.', 'interventionNames': ['Drug: TL-895']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1b, Relapsed/Refractory Myelofibrosis', 'description': '300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.', 'interventionNames': ['Drug: TL-895']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1c, Relapsed/Refractory Myelofibrosis', 'description': '300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.', 'interventionNames': ['Drug: TL-895']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1d, Relapsed/Refractory Myelofibrosis', 'description': '450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.', 'interventionNames': ['Drug: TL-895']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2a, JAKi Intolerant Myelofibrosis', 'description': '150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.', 'interventionNames': ['Drug: TL-895']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2b, JAKi Intolerant Myelofibrosis', 'description': '300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.', 'interventionNames': ['Drug: TL-895']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3a, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L', 'description': '150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.', 'interventionNames': ['Drug: TL-895']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3b, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L', 'description': '300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.', 'interventionNames': ['Drug: TL-895']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5a, Indolent Systemic Mastocytosis', 'description': 'TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with best supportive care (BSC).', 'interventionNames': ['Drug: TL-895']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5b, Indolent Systemic Mastocytosis', 'description': 'TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.', 'interventionNames': ['Drug: TL-895']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5c, Indolent Systemic Mastocytosis', 'description': 'TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.', 'interventionNames': ['Drug: TL-895']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5d, Indolent Systemic Mastocytosis', 'description': 'TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.', 'interventionNames': ['Drug: TL-895']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort 5e, Indolent Systemic Mastocytosis', 'description': 'Placebo to match TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TL-895', 'type': 'DRUG', 'description': 'TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.', 'armGroupLabels': ['Cohort 1a, Relapsed/Refractory Myelofibrosis', 'Cohort 1b, Relapsed/Refractory Myelofibrosis', 'Cohort 1c, Relapsed/Refractory Myelofibrosis', 'Cohort 1d, Relapsed/Refractory Myelofibrosis', 'Cohort 2a, JAKi Intolerant Myelofibrosis', 'Cohort 2b, JAKi Intolerant Myelofibrosis', 'Cohort 3a, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L', 'Cohort 3b, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L', 'Cohort 5a, Indolent Systemic Mastocytosis', 'Cohort 5b, Indolent Systemic Mastocytosis', 'Cohort 5c, Indolent Systemic Mastocytosis', 'Cohort 5d, Indolent Systemic Mastocytosis']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to match TL-895', 'armGroupLabels': ['Cohort 5e, Indolent Systemic Mastocytosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'University of Colorado - Aurora Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic - Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Gabrail Cancer Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of Cincinnati (UC) Physicians Company, LLC', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas, MD Anderson Cancer Center', 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'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.84389, 'lon': 4.42912}}, {'zip': '76805', 'city': 'São Paulo', 'status': 'COMPLETED', 'country': 'Brazil', 'facility': 'Instituto de Estudos e Pesquisas Sao Lucas - IEP - Sao Lucas', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '1431', 'city': 'Sofia', 'status': 'COMPLETED', 'country': 'Bulgaria', 'facility': 'University Hospital "St Ivan Rilski"', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Bulgaria', 'facility': 'Military Medical Academy', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '72037', 'city': 'Le Mans', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'CH Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '44000', 'city': 'Nantes', 'status': 'COMPLETED', 'country': 'France', 'facility': 'CHU de Nantes - Hôtel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': 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'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Policlinico G. 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Jana Mikulicza-Radeckiego we Wroclawiu, Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Daegu', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Seoul', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': "Seoul St. Mary's Hospital, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08908', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': "Institut Catala d'Oncologia - L'Hospitalet", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08916', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Germans Trias i Pujol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '37007', 'city': 'Salamanca', 'status': 'COMPLETED', 'country': 'Spain', 'facility': 'Salamanca University Hospital', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '50006', 'city': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Quirónsalud Zaragoza', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '80756', 'city': 'Kaohsiung City', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Kaohsiung City', 'status': 'COMPLETED', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital - Kaohsiung Branch', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '404', 'city': 'Taichung', 'status': 'COMPLETED', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taipei', 'status': 'COMPLETED', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'John Mei', 'role': 'CONTACT', 'email': 'jmei@teliospharma.com', 'phone': '650-542-0136'}, {'name': 'Emily Houlihan', 'role': 'CONTACT', 'email': 'ehoulihan@teliospharma.com', 'phone': '401-954-8042'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Telios Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}