Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
Study NCT ID:
NCT04689308
Status:
UNKNOWN
Last Update Posted:
2021-09-08
First Post:
2020-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
This is a Phase 1 Study of MH048 in Patients With Selected 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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 57}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2020-12-14', 'studyFirstSubmitQcDate': '2020-12-29', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'Up to approximately 24 Months', 'description': 'Assess incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0'}, {'measure': 'To determine the MTD of MH048', 'timeFrame': 'At the end of Cycle 1( 28 day) of each dose escalation cohort.', 'description': 'If 2 or more treated subjects at a dose level experience a DLT before Day 28, dose escalation will stop and the prior dose level will be considered the MTD for that schedule.'}, {'measure': 'To establish the RP2D.', 'timeFrame': 'Up to approximately 24 Months', 'description': 'The determination of RP2D for phase 2 according to the result of dose expansion cohorts.'}], 'secondaryOutcomes': [{'measure': 'Characterization of Pharmacokinetics (Cmax)', 'timeFrame': 'At the end of Cycle 1 (each cycle is 28 days)', 'description': 'Maximum drug concentration (Cmax)'}, {'measure': 'Characterization of Pharmacokinetics (AUC)', 'timeFrame': 'At the end of Cycle 1 (each cycle is 28 days)', 'description': 'Area Under the Curve (AUC)'}, {'measure': 'Characterization of Pharmacokinetics (CL)', 'timeFrame': 'At the end of Cycle 1 (each cycle is 28 days)', 'description': 'Clearance (CL)'}, {'measure': 'Characterization of Pharmacokinetics (t1/2)', 'timeFrame': 'At the end of Cycle 1 (each cycle is 28 days)', 'description': 'Elimination half-life (t1/2)'}, {'measure': 'Preliminary evidence of anti-tumor activity, in terms of Objective Response Rate (ORR)', 'timeFrame': 'From date of enrollment until the date of best overall response (BoR) of CR or PR, assessed up to approximately 24 months.', 'description': 'The number (%) of subjects with best overall response (BoR) of CR or PR.'}, {'measure': 'Preliminary evidence of anti-tumor activity, in terms of Duration of Response (DOR)', 'timeFrame': 'From the first documented of CR or PR to the first documented PD or death due to any cause, whichever came first, , assessed up to approximately 24 months.', 'description': 'The duration from the first documentation of CR or PR to the first documented PD or death due to any cause, whichever occurs first.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory B-cell Malignancies']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1 study of MH048 in patients with selected Relapsed/Refractory B-cell Malignancies.', 'detailedDescription': 'This is an open-label, multi-center Phase 1 study of MH048 in patients with selected Relapsed/Refractory B-cell Malignancies.\n\nThis study includes 2 parts: Part A is the dose escalation part of the study, and Part B is the dose expansion part of the study. In Part A, patients were enrolled using accelerated titration design for the first three single patient cohorts and 3+3 dose escalation design for the rest cohorts. The starting dose of MH048 in soft gel capsule form was 5 mg/day QD. Cycle length will be 28 days. In Part B, the dose and lymphoma subtypes for expansion phase will depend on the results from Part A.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female subjects ≥18 years of age;\n2. Willing and able to understand and sign an informed consent form and to comply with all aspects of the protocol;\n3. Life expectancy of ≥12 weeks;\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2;\n5. Histologically confirmed B-cell Malignancies who have relapsed or are refractory to standard of care therapies, and have received ≥1 prior lines of therapy:\n\n Part A: Subjects with B-cell Malignancies (regardless of subtype); Part B: Subjects With Selected Relapsed/Refractory B-cell Malignancies based on data from Part A;\n6. There must be radiographically measurable disease for effects assess at dose expansion cohort;\n7. Adequate organ function, as specified below:\n\n Hematologic: Platelet count \\>65 × 10\\^9/L (may be posttransfusion, must one week before the first dose of starting study treatment); Hemoglobin (Hgb) ≥ 80 g/L; international normalized ratio (INR) or plasma prothrombin time (PT) ≤1.5 × ULN; absolute neutrophil count \\>1.0 × 10\\^9/L (growth factor use is allowed to bring pre-treatment neutrophils to \\>1.0 × 10\\^9 cells/L if bone marrow infiltration is involved, provided this is not within 7 days of starting study treatment); Hepatic: Total bilirubin \\<1.5 × upper limit normal (ULN), Total bilirubin \\<3 × ULN for Gilbert Syndrome; Aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤2.5 × ULN; Renal: Creatinine clearance ≥60 mL/min (as estimated by the Cockcroft-Gault equation );\n8. Willing to have bone marrow biopsy/aspirate for baseline disease assessment and assessment of response to treatment;\n9. Willingness of men and women of reproductive potential to observe conventional and highly effective birth control from the beginning of the study screening until 6 months after receiving the last treatment of investigational product. A fertile woman must be confirmed by a positive serum beta-human chorionic gonadotropin \\[β-hCG\\] test before 7 days of starting study treatment.\n\nExclusion Criteria:\n\n1. History of other active malignancies within 1 years of study entry, with the exception of adequately treated in-situ carcinoma of cervix, localized basal cell or squamous cell carcinoma of skin, previous malignancy that was not recurred in 5 years;\n2. History of allogeneic or autologous stem cell transplant or chimeric antigen receptor-modified T-cell (CAR-T) therapy within the past 100 days before starting study treatment, or diagnosis of graft vs host disease;\n3. Clinically significant, uncontrolled cardiac or cardiovascular disease, or history of myocardial infarction, New York Heart Association (NYHA) Class III or IV, QTc prolongation (defined as a QTc \\> 450 ms) or other significant electrocardiogram (ECG) abnormalities including 2nd degree atrioventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min) ,within 6 months prior to planned start of MH048 treatment;\n4. Transformation (e.g., Richter's transformation, prolymphocytic leukemia, or blastoid lymphoma) prior to the planned start of MH048 treatment;\n5. Subjects with known or suspected history of allergy to MH048 capsules or excipients;\n6. Any unresolved toxicities from prior therapy of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v5.0) Grade 2 or higher at the time of starting MH048 treatment, with the exception of toxicities not considered a safety risk (eg, alopecia, neuropathy, or asymptomatic laboratory abnormalities);\n7. Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection;\n8. Active uncontrolled autoimmune disease;\n9. Clinically significant active malabsorption syndrome;\n10. Subjects with human immunodeficiency virus (HIV) , Active hepatitis B virus (HBsAg positive, or HBsAg negative/HBcAb positive ，and HBV DNA\\>10\\^3) or Active HCV infection (HCVAb positive ,and HCV RNA positive);\n11. Major surgery within 4 weeks prior to planned start of MH048 treatment (expect for biopsy, laser eye surgery)；\n12. Women of childbearing potential who are pregnant or lactating;\n13. Subjects requiring therapeutic anticoagulation;\n14. Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of MH048 treatment;\n15. Received a CYP3A4, CYP2A8 strong inhibitor or inducer within 5 half-lives of planned investigational product administration；\n16. Medical history of massive bleeding (hemophilia or other disease need the treatment of blood transfusion）;\n17. Severe neurological/mental illness, and in the opinion of the Investigator, is unable to adhere to the requirements of the study;\n18. Receipt of any investigational agent or clinical study within 28 days;\n19. Unstable brain metastasis patient."}, 'identificationModule': {'nctId': 'NCT04689308', 'briefTitle': 'This is a Phase 1 Study of MH048 in Patients With Selected Relapsed/Refractory B-cell Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Minghui Pharmaceutical (Shanghai) LTD'}, 'officialTitle': 'A Phase 1, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Antitumor Activity of MH048 in Subjects With Selected Relapsed/Refractory B-cell Malignancies', 'orgStudyIdInfo': {'id': 'MH048-CP001CN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Dose Escalation and Determination of RP2D', 'description': 'Part A: Dose Escalation and determination of RP2D, multiple dose levels of MH048 to be evaluated', 'interventionNames': ['Drug: MH048']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Dose Expansion in Selected Relapsed/Refractory B-cell Malignancies', 'description': 'Part B: Selected relapsed/refractory B-NHL subjects with at least 1 prior systemic OR standard-of-care therapy.', 'interventionNames': ['Drug: MH048']}], 'interventions': [{'name': 'MH048', 'type': 'DRUG', 'otherNames': ['MH048 Soft Gel Capsules'], 'description': 'Soft gel capsules 5 mg and 25 mg，oral MH048 should be administered after an overnight fast.', 'armGroupLabels': ['Part A: Dose Escalation and Determination of RP2D', 'Part B: Dose Expansion in Selected Relapsed/Refractory B-cell Malignancies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Jin, M.D.', 'role': 'CONTACT', 'email': 'jiej0503@163.com', 'phone': '+86-0571-87236114'}], 'facility': 'the First Affiliated Hospita，Medicine School of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Jie Jin, MD', 'role': 'CONTACT', 'email': 'jiej0503@163.com', 'phone': '+86 057187236114'}], 'overallOfficials': [{'name': 'Jie Jin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minghui Pharmaceutical (Shanghai) LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}