Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT07264816
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 24 months', 'description': 'ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.'}, {'measure': 'Combined optimal dosage', 'timeFrame': 'Up to approximately 24 months', 'description': 'The combined optimal dosage will be investigated.'}, {'measure': 'Combination method', 'timeFrame': 'Up to approximately 24 months', 'description': 'The combination method will be investigated.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Up to approximately 24 months', 'description': "The PFS is defined as the time from the participant's first dose of BL-M07D1 to the first date of either disease progression or death, whichever occurs first."}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Up to approximately 24 months', 'description': 'The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \\[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\\]).'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 24 months', 'description': "The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first."}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to approximately 24 months', 'description': "Overall survival (OS) is defined as the time between the subject's randomization date and subject's death."}, {'measure': 'Cmax', 'timeFrame': 'Up to approximately 24 months', 'description': 'Maximum serum concentration (Cmax) of BL-M07D1 will be investigated.'}, {'measure': 'Tmax', 'timeFrame': 'Up to approximately 24 months', 'description': 'Time to maximum serum concentration (Tmax) of BL-M07D1 will be investigated.'}, {'measure': 'Ctrough', 'timeFrame': 'Up to approximately 24 months', 'description': 'Ctrough is defined as the lowest serum concentration of BL-M07D1 prior to the next dose will be administered.'}, {'measure': 'Anti-drug antibody (ADA)', 'timeFrame': 'Up to approximately 24 months', 'description': 'Frequency of anti-BL-M07D1 antibody (ADA) will be investigated.'}, {'measure': 'Drug-drug interactions (DDI)', 'timeFrame': 'Up to approximately 24 months', 'description': 'Drug-drug interactions (DDI) will be investigated.'}, {'measure': 'Treatment-Emergent Adverse Event (TEAE)', 'timeFrame': 'Up to approximately 24 months', 'description': 'TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-squamous Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This trial is a multicenter, open-label, Phase II clinical study to explore the efficacy and safety of BL-M07D1 in combination with pembrolizumab in patients with locally advanced or metastatic HER2-overexpressing non-squamous non-small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restrictions;\n3. Age at the time of signing the informed consent form ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Patients with locally advanced or metastatic non-squamous non-small cell lung cancer;\n6. Confirmed known HER2 overexpression;\n7. Agree to provide archived tumor tissue specimens from primary or metastatic lesions within the past 2 years;\n8. Must have at least one measurable lesion meeting the RECIST v1.1 criteria;\n9. ECOG performance status score of 0 or 1;\n10. Toxicities from prior anti-tumor treatments have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n11. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n12. Organ function levels must meet the requirements;\n13. For premenopausal women with childbearing potential, a pregnancy test must be conducted within 7 days before starting treatment, serum pregnancy must be negative, and they must not be breastfeeding; all enrolled patients (regardless of gender) should take adequate and highly effective contraception throughout the treatment cycle and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Underwent surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks before the first dose or within 5 half-lives;\n2. Pathology indicates non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;\n3. Previously received HER2-targeted therapy or ADC drug treatment with camptothecin derivatives as toxins;\n4. History of severe cardiovascular or cerebrovascular diseases within the past 6 months before screening;\n5. Concurrent pulmonary disease leading to severe impairment of lung function;\n6. QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;\n7. Diagnosed with other primary malignancies within 5 years before the first dose;\n8. Poorly controlled hypertension;\n9. History of non-infectious ILD requiring steroid treatment, or currently suffering from ILD/interstitial pneumonia, etc.;\n10. Patients with central nervous system metastases, carcinomatous meningitis, and/or spinal cord compression;\n11. Patients with a history of allergy to recombinant humanized antibodies or allergy to BL-M07D1, pembrolizumab, or any excipient components;\n12. Required systemic corticosteroid or immunosuppressive therapy within 2 weeks before the study administration;\n13. Patients with massive serous cavity effusion, symptomatic serous cavity effusion, or poorly controlled serous cavity effusion;\n14. New deep vein thrombosis within 14 days, excluding patients with venous filters implanted;\n15. Systemic severe infection within 4 weeks before screening;\n16. Active autoimmune diseases and inflammatory diseases;\n17. Human immunodeficiency virus antibody positivity, active hepatitis B virus infection, or hepatitis C virus infection;\n18. History of allogeneic stem cell, bone marrow, or organ transplantation;\n19. Presence of severe neurological or psychiatric disorders;\n20. Presence of other severe physical or laboratory abnormalities, poor compliance, etc., which may increase the risk of participation in the study, interfere with study results, or patients deemed unsuitable for participation in the study by the investigator.'}, 'identificationModule': {'nctId': 'NCT07264816', 'briefTitle': 'A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sichuan Baili Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'BL-M07D1-207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BL-M07D1+pembrolizumab', 'description': 'Participants received BL-M07D1+pembrolizumab in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.', 'interventionNames': ['Drug: BL-M07D1', 'Drug: Pembrolizumab']}], 'interventions': [{'name': 'BL-M07D1', 'type': 'DRUG', 'description': 'Administration by intravenous infusion for a cycle of 3 weeks.', 'armGroupLabels': ['BL-M07D1+pembrolizumab']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Administration by intravenous infusion for a cycle of 3 weeks.', 'armGroupLabels': ['BL-M07D1+pembrolizumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'Qian Chu', 'role': 'CONTACT'}], 'facility': 'Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Sa Xiao, PHD', 'role': 'CONTACT', 'email': 'xiaosa@baili-pharm.com', 'phone': '15013238943'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan Baili Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}