Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-29 @ 6:27 PM
Study NCT ID:
NCT06092268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2023-10-08', 'studyFirstSubmitQcDate': '2023-10-17', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose-limiting toxicity (DLT) (phase IB)', 'timeFrame': '21 days after the first dose was administered to each subject.'}, {'measure': 'Objective Response Rate (ORR) (phase II).', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'PK parameter: toxin-binding antibody of SHR-A2009', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'PK parameter: total antibody of SHR-A2009', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'PK parameter: free toxin of SHR-A2009', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'Plasma concentration of Adebrelimab', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'Immunogenicity of SHR-A2009 and Adebrelimab (Anti-SHR-A2009 antibody, anti- Adebrelimab antibody ) (Phase IB)', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'Duration of response(DoR )', 'timeFrame': 'One year after the last subject was enrolled in the group'}, {'measure': 'Progression Free Survival(PFS)', 'timeFrame': '2 years after the last subject was enrolled in the group'}, {'measure': 'Objective response rate', 'timeFrame': '2 years after the last subject was enrolled in the group'}, {'measure': 'overall survival (OS) (phase IB)', 'timeFrame': '3 years after the last subject was enrolled in the group'}, {'measure': 'Incidence of AEs（Phase II (efficacy expansion phase)）', 'timeFrame': 'from Day1 to 90 days after last dose'}, {'measure': 'Incidence of SAEs（Phase II (efficacy expansion phase)）', 'timeFrame': 'from Day1 to 90 days after last dose'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in combination with other antitumor therapies 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. Age 18 to 75 years old (inclusive), Female or male\n2. Subjects with unresectable locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology\n3. Previously treated by EGFR-TKI or other standard treatment or have not been treated for metastatic setting;\n4. At least one measurable tumor lesion according to RECIST v1.1 (enrollment of subjects with only non-target lesions is permitted in Stage IB phase)\n5. ECOG performance score of 0-1;\n6. Expected survival time ≥ 12 weeks;\n7. Adequate bone marrow and organ function\n8. Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Subjects with active central nervous system (CNS) metastases.\n2. Spinal cord compression not cured by surgery and/or radiotherapy cannot be enrolled.\n3. Subjects with uncontrolled tumor-related pain\n4. Clinically uncontrollable third space fluid\n5. Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;\n6. Received \\>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;\n7. Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;\n8. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;\n9. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function\n10. Serious cardiovascular disease\n11. Presence of refractory nausea, vomiting, chronic gastrointestinal disease, etc.; subjects with active, known or suspected autoimmune diseases\n12. Presence of severe infection within 4 weeks prior to first dose of study drug\n13. Subjects with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug\n14. Arterial/venous thrombotic events within 3 months prior to the first study dose\n15. History of immunodeficiency, including a positive HIV test\n16. Presence of active hepatitis B or C;\n17. History of severe allergic reactions to other monoclonal antibodies or allergic reactions to any component of the SHR-A2009 product.\n18. Known history of alcohol or drug dependence or addiction;\n19. Persons with mental disorders or poor compliance;'}, 'identificationModule': {'nctId': 'NCT06092268', 'briefTitle': 'A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A2009 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'SHR-A2009-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Part A: SHR-A2009 for injection in combination with Almonertinib Mesilate Tablets', 'interventionNames': ['Drug: SHR-A2009 for injection ； Almonertinib Mesilate Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Part B: SHR-A2009 for injection in combination with Adebrelimab Injection', 'interventionNames': ['Drug: SHR-A2009 for injection；Adebrelimab Injection']}], 'interventions': [{'name': 'SHR-A2009 for injection ； Almonertinib Mesilate Tablets', 'type': 'DRUG', 'description': "Phase IB: SHR-A2009 will be administered intravenously，Almonertinib Mesilate Tablets will be administered orally. 2 or 3 dose levels are preset in phase IB.\n\nPhase II: 2 dose cohorts will be selected and it's randomization.", 'armGroupLabels': ['Treatment Part A: SHR-A2009 for injection in combination with Almonertinib Mesilate Tablets']}, {'name': 'SHR-A2009 for injection；Adebrelimab Injection', 'type': 'DRUG', 'description': 'Phase IB: SHR-A2009 and Adebrelimab will be administered intravenously. 2 dose levels are preset in phase IB.\n\nPhase II: RPD2 will be selected to evaluate preliminary efficacy.', 'armGroupLabels': ['Treatment Part B: SHR-A2009 for injection in combination with Adebrelimab Injection']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Fei Qiu', 'role': 'CONTACT', 'email': 'fei.qiu@hengrui.com', 'phone': '0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}