Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 8:46 AM
Study NCT ID:
NCT06368960
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-11', 'studyFirstSubmitDate': '2024-04-07', 'studyFirstSubmitQcDate': '2024-04-11', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT and MTD', 'timeFrame': 'Up to 14 days after the initial treatment', 'description': 'Dose limiting toxicity and maximum tolerated dose'}, {'measure': 'Pharmacokinetic (PK) parameters', 'timeFrame': 'From pre-dose to 96 hrs post-dose', 'description': 'Maximum plasma concentration(Cmax) of the drug after administration'}, {'measure': 'Number of patients with adverse events (AEs)', 'timeFrame': 'From the first treatment to 42 days after the last treatment.', 'description': 'Number of patients with treatment-related adverse events (AEs)'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'Up to 42 days after the last treatment', 'description': 'Objective Response Rate'}, {'measure': 'Peripheral blood cytokine profiling in study participants.', 'timeFrame': 'From pre-dose/pre-radiation to 4 hrs post-dose/post-radiation.', 'description': 'To investigate the change of peripheral blood cytokine level in subjects after the treatment.'}, {'measure': 'The variation in peripheral blood tumor biomarker concentrations.', 'timeFrame': 'Up to 42 days after the last treatment', 'description': 'The variation of concentrations of AFP，NSE，CEA ；'}, {'measure': 'Other exploring outcomes', 'timeFrame': 'Up to 14 days after the initial treatment', 'description': 'The variation of tumor tissue biomarker expression levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is a non-randomized，open-label，controlled multi-center Phase Ⅰ study to evaluate tolerability, pharmacokinetics, and preliminary efficacy of BM201 injection in combination with radiotherapy in patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors who have failed standard therapy or are unable to receive standard treatment.', 'detailedDescription': 'This is a Phase I, open-label clinical study primarily designed to evaluate the safety and tolerability of BM201 injection in combination with radiotherapy in patients with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Unresectable advanced or metastatic solid tumors, either refractory to standard therapy or ineligible for standard treatment.\n2. ECOG performance status score of 0-2 point;\n3. Expected survival of ≥3 months.\n4. At least one measurable lesion by irRECIST criteria, and eligible for intratumoral injection.\n5. Prior anti-tumor treatments should be paused for at least 4 weeks before trial initiation，with toxicity related to anti-cancer treatment recovered to ≤Grade 1.\n6. Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n1. Patients with active brain metastasis and/or leptomeningeal carcinomatosis，exempt for asymptomatic brain metastases or stable metastatic lesions for a minimum of 4 weeks.\n2. Allergic: History of hypersensitivity to active ingredients or any other components of the study medication; cumulative two or more allergies to contrast agents, other drugs, or food.\n3. Active hepatitis B or positive antibodies for hepatitis C, human immunodeficiency virus (HIV), or syphilis.\n4. Severe cardiac or cerebrovascular conditions, uncontrolled diabetes, hypertension not well-managed medically (systolic \\>140 mmHg and/or diastolic \\>90 mmHg), serious infections (active within 14 days before first drug administration/radiotherapy), active GI ulcers, and immune dysfunction.\n5. Presence of other active malignancies or history thereof, except for previously managed non-invasive skin basal or squamous cell carcinomas with a 5-year recurrence-free interval, cervical carcinoma in situ, and ductal carcinoma in situ of the breast.\n6. Uncontrolled third-space effusions such as pericardial, abdominal, or pleural within 2 weeks before the initial treatment.\n7. Administration of corticosteroids within the preceding 2 weeks before initial treatment.\n8. Receipt of vaccination within 2 weeks prior to initial therapy.\n9. Participation in clinical trial involving drugs or biologics within 4 weeks before the initial treatment.\n10. History of major surgery within 3 months prior to initial treatment or scheduled major surgery during the clinical trial period.\n11. Prior blood donation or major hemorrhage (\\>450 mL) within 3 months before initial therapy, or intention to donate blood/blood components during or within 3 months after the trial.\n12. Patients with difficult venous access or intolerance to venipuncture, and those unable to tolerate intratumoral injection.\n13. Pregnant (positive pregnancy test) and lactating females.\n14. Subjects planning pregnancy or gamete donation within 3 months post-consent and unwilling to practice effective contraception.\n15. Patients deemed ineligible for enrollment by the investigator.'}, 'identificationModule': {'nctId': 'NCT06368960', 'acronym': 'BM201-1001', 'briefTitle': 'BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'InnoBM Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'The Study to Evaluate the Safety, PK, and Preliminary Efficacy of BM201 Injection Combined With Radiotherapy in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors That Failed Standard Therapy', 'orgStudyIdInfo': {'id': 'BM201-1001'}, 'secondaryIdInfos': [{'id': 'CTR20223162', 'type': 'REGISTRY', 'domain': 'National Medical Products Administration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiotherapy', 'description': 'Radiation：Hypofractionated radiotherapy', 'interventionNames': ['Radiation: Radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'BM201 injection combined with radiotherapy', 'description': 'BM201 injection：Intratumoral injection Radiation：Hypofractionated radiotherapy', 'interventionNames': ['Radiation: Radiotherapy', 'Drug: BM201 injection']}], 'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'otherNames': ['RT'], 'description': 'Radiation： Hypofractionated radiotherapy', 'armGroupLabels': ['BM201 injection combined with radiotherapy', 'Radiotherapy']}, {'name': 'BM201 injection', 'type': 'DRUG', 'otherNames': ['BM201'], 'description': 'BM201 injection：Dose escalation：24mg to 240mg', 'armGroupLabels': ['BM201 injection combined with radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juan L GCP Director', 'role': 'CONTACT', 'email': 'njglyygcp@163.com', 'phone': '800-555-5555'}, {'name': 'Baorui L Chief Physician', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Chuntao G PM', 'role': 'CONTACT', 'email': 'ctgong@innobm.cn', 'phone': '86+0512 6938 6599'}], 'overallOfficials': [{'name': 'Baorui L Chief Physician, PH.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InnoBM Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}