Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT07114367
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NB02(POSELTINIB) Monotherapy in R/R Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720850', 'term': 'poseltinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2025-08-03', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MTD(maximum tolerated dose) or OBD(optimal biological dose)', 'timeFrame': 'Approximately 48 Months', 'description': 'MTD(maximum tolerated dose) or OBD(optimal biological dose)'}, {'measure': 'AEs', 'timeFrame': 'Approximately 48 Months', 'description': 'AEs'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic (PK) Ctrough', 'timeFrame': 'Day 147', 'description': 'Pharmacokinetic (PK) parameters from plasma samples'}, {'measure': 'Pharmacokinetic (PK) t1/2', 'timeFrame': 'Day 147', 'description': 'Pharmacokinetic (PK) parameters from plasma samples'}, {'measure': 'Pharmacokinetic (PK) CL/F', 'timeFrame': 'Day 147', 'description': 'Pharmacokinetic (PK) parameters from plasma samples'}, {'measure': 'Pharmacokinetic (PK) Vz/F', 'timeFrame': 'Day 147', 'description': 'Pharmacokinetic (PK) parameters from plasma samples'}, {'measure': 'Pharmacokinetic (PK) Cmax', 'timeFrame': 'Day 147', 'description': 'Pharmacokinetic (PK) parameters from plasma samples'}, {'measure': 'Pharmacokinetic (PK) AUCtau', 'timeFrame': 'Day 147', 'description': 'Pharmacokinetic (PK) parameters from plasma samples'}, {'measure': 'Pharmacokinetic (PK) Tmax', 'timeFrame': 'Day 147', 'description': 'Pharmacokinetic (PK) parameters from plasma samples'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'Approximately 48 Months', 'description': 'To evaluate preliminary anti-tumor activity'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'Approximately 48 Months', 'description': 'To evaluate preliminary anti-tumor activity'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'Approximately 48 Months', 'description': 'To evaluate preliminary anti-tumor activity'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Approximately 48 Months', 'description': 'To evaluate preliminary anti-tumor activity'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Approximately 48 Months', 'description': 'To evaluate preliminary anti-tumor activity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Relapsed', 'Refractory', 'Lymphoma', 'NHL', 'FL', 'MCL', 'MZL'], 'conditions': ['Non Hodgkin Lymphoma (NHL)']}, 'descriptionModule': {'briefSummary': 'This trial is an open-label, multicenter, monotherapy, dose-escalation, phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of NB02 (posseltinib) in patients with relapsed/refractory NHL including FL, MCL and MZL', 'detailedDescription': 'The study will conduct dose-finding. The dose-finding will be set as 3+3 design to seek candidates for optimal doses. Patients will receive study drugs to determine the MTD and/or OBD. In this study, OBD is defined as the most reasonable dose considering the benefit/risk ratio from available non-clinical and clinical data. The OBD will be determined based on available safety, PK/PD, and preliminary efficacy data, with a focus on identifying the dose that optimally balances clinical activity and tolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 19 to 80 years.\n2. Patients must voluntarily agree to participate in the study and provide written informed consent prior to any study-related procedures.\n3. Patients with histologically confirmed follicular lymphoma, mantle cell lymphoma or marginal zone lymphoma.\n4. relapsed/refractory Patients who have received more than two prior lines of therapy.\n5. Measurable disease based on Lugano classification (e.g., at least one lesion ≥ 1.5 cm on CT or PET-CT).\n6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n7. Adequate organ function including:\n\nExclusion Criteria:\n\n1. Previous treatment with NB02 (poseltinib).\n2. Patients who have experienced progression on BTKi mono or BTKi containing regimen (However, patients who discontinued treatment due to adverse-effect-related intolerance or for economic or social reasons remain eligible for enrollment).\n3. Unable to take oral medication.\n4. Inability to comply with study and follow-up procedures.\n5. Concurrent use of other investigational drugs or enrollment in another clinical trial within 4 weeks prior to study drug administration.\n6. Patients who have previously been treated with NB02 (poseltinib) or any other BTK inhibitors (e.g., ibrutinib, acalabrutinib, zanubrutinib).\n7. Known HIV, HCV and HBV infection with active diseases'}, 'identificationModule': {'nctId': 'NCT07114367', 'acronym': 'POTENTIAL-M', 'briefTitle': "NB02(POSELTINIB) Monotherapy in R/R Non-Hodgkin's Lymphoma", 'organization': {'class': 'INDUSTRY', 'fullName': 'NOBO Medicine'}, 'officialTitle': "An Open-Label, Multicenter, Monotherapy, Dose-Escalation, Phase 1 Clinical Trial of NB02 (Posseltinib) in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'NB02-L02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NB02 (Poseltinib)', 'description': 'Dose Level 1 Dose Level 2 Dose Level 3', 'interventionNames': ['Drug: NB02 (Poseltinib)']}], 'interventions': [{'name': 'NB02 (Poseltinib)', 'type': 'DRUG', 'description': 'Dose Level 1, Dose Level 2, Dose Level 3', 'armGroupLabels': ['NB02 (Poseltinib)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NOBO Medicine', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}