Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-29 @ 3:52 AM
Study NCT ID:
NCT04984434
Status:
UNKNOWN
Last Update Posted:
2021-07-30
First Post:
2021-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of F182112 in Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2021-07-21', 'studyFirstSubmitQcDate': '2021-07-21', 'lastUpdatePostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Minimal Residual Disease (MRD) Negative Rate', 'timeFrame': 'Approximately 24 months', 'description': 'Minimal Residual Disease (MRD) Negative Rate'}], 'primaryOutcomes': [{'measure': 'DLTs', 'timeFrame': 'Up to 28 days', 'description': 'Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period'}, {'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': 'Approximately 12 months', 'description': 'Maximum Tolerated Dose'}, {'measure': 'RP2D', 'timeFrame': 'Approximately 12 months', 'description': 'Preliminary Antitumor Activity of F182112 at the RP2D(s) in Part 2'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Approximately 24 months', 'description': 'To evaluate the duration from the first dose to death of patients with MM for any reason.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Approximately 24 months', 'description': 'Evaluation of the efficacy of F182112 in patients with MM on progression-free survival.'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Approximately 24 months', 'description': 'Objective remission rate was used to evaluate the efficacy of F182112 injection in patients with MM.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dose-Escalation Study, Relapsed or Refractory Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This trial is a Multiple center, Open-label, dose escalation Phase Ⅰ clinical study. The purpose is to evaluate the safety and tolerability of F182112 when infused intravenously (IV) and determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of F182112 when infused IV.', 'detailedDescription': 'To assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) of F182112 as monotherapy in patients with relapsed or refractory multiple myeloma (MM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures;\n\n 2\\) Male or female ≥ 18 years;\n\n 3\\) Patient has a history of multiple myeloma with relapsed and refractory disease, and must:\n 1. Relapsed after an autologous stem cell transplant (ASCT), or not suitable for ASCT;\n 2. Must have received at least 2 prior multiple myeloma treatment regimens (not including autologous stem cell transplant) including a proteasome inhibitor, an immunomodulatory agent;\n\n 4\\) ECOG of 0-2;\n\n 5\\) Patients must have measurable disease, including at least one of the criteria below:\n\n <!-- -->\n\n 1. M-protein ≥ 0.5 g/dL by SPEP/immunofixation or\n 2. ≥ 200 mg/24 hours urine collection by UPEP or\n 3. Serum free light chain (FLC) levels \\> 100 mg/L (milligrams/liter involved light chain) and an abnormal kappa/lambda (κ/λ) ratio in patients without detectable serum or urine M-protein;\n\n 6\\) Adequate hepatic function as evidenced by meeting all the following requirements:\n\n <!-- -->\n\n 1. Blood routine: absolute neutrophil count (ANC) ≥ 1.0×109/L, hemoglobin (Hb) ≥70g/L, Platelet ≥ 50×109/L;\n 2. Liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 × ULN, Aspartate aminotransferase (AST) ≤ 2.5 × ULN;\n 3. Renal function: calculated creatinine clearance (CrCL) ≥ 30 mL/min (Cockroft-Gault Equation).\n\n 7\\) Recovery to Grade 0-1 from adverse events related to prior anticancer therapy except alopecia, ≤ Grade 2 sensory neuropathy, lymphopenia, and endocrinopathies controlled with hormone replacement therapy.\n\n Exclusion Criteria:\n* 1\\) Patient has primary light chain amyloidosis or plasma cell leukemia;\n\n 2\\) Patient has symptomatic central nervous system involvement of multiple myeloma;\n\n 3\\) Received systemic anti-myeloma therapy within 2 weeks, or received plasma exchange within 4 weeks;\n\n 4\\) Received any experimental drugs within 4 weeks or 5 half-lives (whichever is shorter);\n\n 5\\) Patient has received ≥ 40 mg/day dexamethasone equivalent within 7 days before starting F182112. Short term use of corticosteroids at doses equivalent to \\> 10 mg/d of prednisone；\n\n 6\\) Received any monoclonal antibody therapy within 30 days;\n\n 7\\) Prior treatment with any B cell maturation antigen (BCMA) targeted therapy;\n\n 8\\) Patient had a prior allogeneic stem cell transplant or had a prior autologous stem cell transplant ≤ 3 months prior to starting F182112;\n\n 9\\) Live virus vaccine within 30 days prior to study entry;\n\n 10\\) Major surgery within 4 weeks prior to study entry;\n\n 11\\) Concurrent malignancy within 3 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer under active surveillance, prostate cancer that has undergone definitive treatment, ductal carcinoma in situ of the breast, or ≤ T1 urothelial carcinoma;\n\n 12\\) Patients with active mucosa or visceral bleeding;\n\n 13\\) Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry; NYHA class III or IV heart failure within 6 months of study entry; Uncontrolled arrhythmia within 6 months of study entry. Patients with a rate-controlled arrhythmia may be eligible for study entry at the discretion of the Medical Monitor;\n\n 14\\) Active infection requiring antibiotic, antiviral or antifungul therapy;\n\n 15\\) Active viral hepatitis;\n\n 16\\) Has a history of immunodeficiency, include HIV infection;\n\n 17\\) Treponema pallidum infection;\n\n 18\\) Received any experimental drugs or anti-tumor drugs within 2 weeks;\n\n 19\\) Subject has any condition that confounds the ability to interpret data from the study;\n\n 20\\) Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and 6 months after the last giving F182112;\n\n 21\\) Any condition that the investigator or primary physician believes may not be appropriate for participating the study.'}, 'identificationModule': {'nctId': 'NCT04984434', 'briefTitle': 'Phase 1 Study of F182112 in Patients With Relapsed or Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong New Time Pharmaceutical Co., LTD'}, 'officialTitle': 'A First-in-human, Open-label, Multiple Center Phase 1 Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetic, Immunogenicity, and Preliminary Efficacy of F182112 in Patients With Relapsed or Refractory Multiple Myeloma.', 'orgStudyIdInfo': {'id': 'NTP-F182112-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Single Arm', 'interventionNames': ['Drug: F182112']}], 'interventions': [{'name': 'F182112', 'type': 'DRUG', 'description': 'Eight dose cohorts: 0.01, 0.1, 0.3, 1, 3, 10, 20 and 30 μg/kg) d1 treat every weeks.', 'armGroupLabels': ['Experimental: Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '276006', 'city': 'Linyi', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaohong Yin', 'role': 'CONTACT', 'email': 'yinshaohong@lunan.com.cn', 'phone': '86-15265901803'}, {'name': 'JunYuan Qi, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shaohong Yin', 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong New Time Pharmaceutical Co., LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}