Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2026-01-19 @ 6:54 AM
Study NCT ID:
NCT06590961
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2024-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase 1a: Dose escalation study Phase 1b: Dose expansion study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-09-08', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with Protocol Specified Dose-Limiting Toxicities', 'timeFrame': '28-days', 'description': 'Phase 1a and 1b'}, {'measure': 'To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)', 'timeFrame': 'Up to End of Treatment (up to 9 months)', 'description': 'Phase 1a and 1b'}, {'measure': 'Number of subjects with dose interruptions, reductions, and doses administered', 'timeFrame': 'Up to End of Treatment (up to 9 months)', 'description': 'Phase 1a and qb'}], 'secondaryOutcomes': [{'measure': 'To evaluate the anti-tumor activity of UBX-303061 in the dose levels based on Best overall response', 'timeFrame': 'Up to End of Treatment (up to 9 months)', 'description': 'Phase 1a and 1b'}, {'measure': 'To assess genetic markers including but not limited to BTK, PLCG2, MYD88', 'timeFrame': 'Up to End of Treatment (up to 9 months)', 'description': 'Phase 1a and 1b'}, {'measure': 'To assess Cmin', 'timeFrame': '28-days', 'description': 'Phase 1a and 1b'}, {'measure': 'To assess tmax', 'timeFrame': '28-days', 'description': 'Phase 1a and 1b'}, {'measure': 'To assess AUC', 'timeFrame': '28-days', 'description': 'Phase 1a and 1b'}, {'measure': 'To assess Cmax', 'timeFrame': '28-days', 'description': 'Phase 1a and 1b'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory B-cell Malignancies']}, 'descriptionModule': {'briefSummary': 'This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of UBX-303061 in patients with relapsed/refractory B-cell malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria\n\n* Capable of giving signed informed consent\n* Age ≥18 years\n* ECOG performance status ≤2.\n* Phase Ia (dose-escalation part only): Subjects with relapsed and/or refractory B-cell malignancies (CLL/SLL, DLBCL, FL, MCL, WM or MZL) who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion.\n* Phase Ib (dose-expansion only): Subjects with relapsed and/or refractory B-cell malignancies who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion, and fit into one of the following groups: CLL/SLL or DLBCL or MCL or FL, WM, MZL\n* All subjects must have evaluable or measurable disease based on the appropriate tumor type criteria\n* Adequate organ and bone marrow function\n\nKey Exclusion Criteria\n\n* For subjects with lymphoma:\n\n * Systemic antineoplastic therapy or any experimental therapy within 3 weeks or 5 half-lives, whichever is shorter, before the first dose of study treatment.\n * Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.\n * Unconjugated monoclonal antibody therapies \\<6 weeks before the first dose of study treatment.\n * Subjects that have undergone autologous stem cell rescue within 100 days prior to the first dose of study treatment.\n * Subjects that have undergone allogeneic stem cell transplant within 6 months prior to the first dose of study treatment.\n * Subjects with active graft-versus-host disease (GVHD) or on anti-GVHD treatment or prophylaxis.\n * History of chimeric antigen receptor T cell (CAR-T) therapy within 100 days prior to start of study drug.\n * Any immunotherapy within 4 weeks of first dose of study drug.\n * The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drug is \\<5 times the t1/2 of the previously administered agent(s).\n* Previously exposed to BTK degradation therapy\n* Malignant disease, other than that being treated in this study.\n* Radiotherapy within 2 weeks of the first dose of study treatment\n* Known hypersensitivity to BTK degraders or any of the ingredients.\n* Impaired cardiac function or clinically significant cardiac disease\n* Subjects with history of severe bleeding disorders and known/suspected other autoimmune disease\n* Major surgery within 4 weeks of the first dose of study treatment"}, 'identificationModule': {'nctId': 'NCT06590961', 'briefTitle': 'UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ubix Therapeutics, Inc.'}, 'officialTitle': 'A Phase Ia/Ib, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic of UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies', 'orgStudyIdInfo': {'id': 'UBX-303-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UBX-303061', 'description': 'UBX-303061', 'interventionNames': ['Drug: UBX-303061']}], 'interventions': [{'name': 'UBX-303061', 'type': 'DRUG', 'description': 'UBX-303061 oral dosage', 'armGroupLabels': ['UBX-303061']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '44718', 'city': 'Canton', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Gabrail Cancer Center', 'geoPoint': {'lat': 36.05365, 'lon': -98.58842}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '87-100', 'city': 'Torun', 'state': 'Kuyavian-Pomeranian Voivodeship', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'facility': 'MICS Centrum Medyczne Toruń', 'geoPoint': {'lat': 53.01375, 'lon': 18.59814}}, {'zip': '02-172', 'city': 'Warsaw', 'state': 'Mazowieckie Voivodeship', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'facility': 'Pratia, MTZ Clinical Research', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '40-519', 'city': 'Katowice', 'state': 'Silesian Voivodeship', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'facility': 'Pratia, Oncology Katowice', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '62-065', 'city': 'Grodzisk Wielkopolski', 'state': 'Wielkopolskie Voivodeship', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'facility': 'AidPort', 'geoPoint': {'lat': 52.22762, 'lon': 16.36534}}, {'zip': '05505', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07345', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Yeouido St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Project Manager', 'role': 'CONTACT', 'email': 'ubix_co@ubixtrx.com', 'phone': '+82 (2) 6334 2475'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ubix Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}