Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-01-01 @ 9:35 PM
Study NCT ID:
NCT06678659
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2024-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '"Phase 1a: Dose Escalation Phase 1b: Randomized Phase 2: Non-Randomized"'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2024-11-05', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1-Part 1A (Dose Finding)- Assessment of Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Initiation of study drug through 4 weeks', 'description': 'To characterize the incidence of DLTs'}, {'measure': 'Phase 1 and 2 -Treatment-emergent Adverse Events', 'timeFrame': 'Initiation of study drug through 30 days after the last dose (up to approximately 24 months)', 'description': 'To characterize the incidence of treatment emergent adverse events'}, {'measure': 'Phase 2- Objective Response Rate (ORR)', 'timeFrame': 'Initiation from study drug until disease progression (up to approximately 24 months)', 'description': 'To assess tumor response'}], 'secondaryOutcomes': [{'measure': 'Phase 1- ORR', 'timeFrame': 'Initiation from study drug until disease progression (up to approximately 24 months)', 'description': 'To assess tumor response'}, {'measure': 'Phase 1 and 2- Disease Control Rate (DCR)', 'timeFrame': 'Initiation from study drug until disease progression as applicable (up to approximately 24 months)', 'description': 'To assess the anti-tumor activity'}, {'measure': 'Phase 1 and 2 - Duration of Response (DOR)', 'timeFrame': 'Initiation from study drug until disease progression as applicable (up to approximately 24 months)', 'description': 'To assess the anti-tumor activity'}, {'measure': 'Phase 1 and 2 - Duration of Stable Disease (SD)', 'timeFrame': 'Initiation from study drug until disease progression as applicable (up to approximately 24 months)', 'description': 'To assess the anti-tumor activity'}, {'measure': 'Phase 1 and 2 - Time to Response (TTR)', 'timeFrame': 'Initiation from study drug until disease progression as applicable (up to approximately 24 months)', 'description': 'To assess the anti-tumor activity'}, {'measure': 'Phase 1 and 2 - Progression Free Survival (PFS)', 'timeFrame': 'Initiation from study drug until disease progression as applicable (up to approximately 24 months)', 'description': 'To assess the anti-tumor activity'}, {'measure': 'Phase 1 and 2 - Overall Survival (OS)', 'timeFrame': 'Initiation from study drug until disease progression as applicable (up to approximately 24 months)', 'description': 'To assess the anti-tumor activity'}, {'measure': 'Phase 1 - Maximum Plasma Concentration (Cmax)', 'timeFrame': 'Initiation of study drug through Week 9', 'description': 'To characterize PK of REC-1245'}, {'measure': 'Phase 1 - Time to Reach Maximum Plasma Concentration (Tmax)', 'timeFrame': 'Initiation of study drug through Week 9', 'description': 'To characterize PK of REC-1245'}, {'measure': 'Phase 1 - Plasma Concentration Before the Next Dose (Ctrough)', 'timeFrame': 'Initiation of study drug through Week 9', 'description': 'To characterize PK of REC-1245'}, {'measure': 'Phase 1 - Area Under Plasma Concentration-time Curve (AUC)', 'timeFrame': 'Initiation of study drug through Week 9', 'description': 'To characterize PK of REC-1245'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RBM39', 'Cancer', 'Refractory Lymphomas', 'Metastatic Cancers'], 'conditions': ['Unresectable', 'Locally Advanced', 'Metastatic Cancers', 'Relapsed/Refractory Lymphomas']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors.', 'detailedDescription': 'Approximately 85 participants will be enrolled in this open-label Phase 1/2 study, allocated 55 participants in Phase 1 and 10-30 participants in Phase 2. The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of REC-1245 for the treatment of participants with unresectable locally advanced or metastatic solid tumors. Participants will receive treatment with REC-1245 for up to 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Have histologically-confirmed unresectable, locally advanced, or metastatic select solid tumors or select relapsed / refractory lymphoma\n* Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or have been considered ineligible for standard therapy.\n* Eastern cooperative oncology group (ECOG) performance status ≤ 1\n* Measurable disease at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 / Lugano criteria and documented by computed tomography (CT) and / or magnetic resonance imaging (MRI)\n\nExclusion Criteria:\n\n* Received treatment with another RBM39 degrader\n* Clinically significant gastrointestinal (GI) or GI malabsorption'}, 'identificationModule': {'nctId': 'NCT06678659', 'acronym': 'DAHLIA', 'briefTitle': 'A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Recursion Pharmaceuticals Inc.'}, 'officialTitle': 'A Phase 1 / 2, Open-Label Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer', 'orgStudyIdInfo': {'id': 'REC-1245-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1a', 'description': 'Dose Escalation', 'interventionNames': ['Drug: REC-1245']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b Dose #1', 'interventionNames': ['Drug: REC-1245']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b Dose #2', 'interventionNames': ['Drug: REC-1245']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2', 'description': 'At recommended Phase 2 dose (RP2D)', 'interventionNames': ['Drug: REC-1245']}], 'interventions': [{'name': 'REC-1245', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['Phase 1a', 'Phase 1b Dose #1', 'Phase 1b Dose #2', 'Phase 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mihae Song', 'role': 'CONTACT', 'email': 'misong@coh.org', 'phone': '8774673411'}], 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Grenbenc', 'role': 'CONTACT', 'email': 'canceranswer@ccf.org', 'phone': '216-444-7923'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'SCRI Oncology Partners - PPDS', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84119', 'city': 'West Valley City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marie Asay', 'role': 'CONTACT', 'email': 'marie.asay@startresearch.com', 'phone': '(801) 907-4750'}], 'facility': 'START Mountain Region', 'geoPoint': {'lat': 40.69161, 'lon': -112.00105}}, {'zip': 'H4A3J1', 'city': 'Québec', 'state': 'Canada', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Phuong-nam Nguyen', 'role': 'CONTACT', 'email': 'Phuong-nam.Nguyen@muhc.mcgill.ca', 'phone': '5149341934'}], 'facility': 'McGill University Health Centre (MUHC) - The Montreal', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'M5G 1X6', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Anh Nguyen', 'role': 'CONTACT', 'email': 'anh.nguyen2@uhn.ca', 'phone': '416-946-4501'}], 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recursion Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}