Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-27 @ 11:10 PM
Study NCT ID:
NCT07055594
Status:
RECRUITING
Last Update Posted:
2025-11-06
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-07-07', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) of SOA101 for Phase I', 'timeFrame': 'from start until 3 months after the last dosing'}, {'measure': 'Objective Response Rate (ORR) of SOA101 for Phase IIa', 'timeFrame': 'from start until 3 months after the last dosing'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve of SOA101 (AUC)', 'timeFrame': 'Up to end of study visit (90 days after the last dose)', 'description': 'Pharmacokinetics (PK) parameters'}, {'measure': 'Maximum observed plasma concentration of SOA101 (Cmax)', 'timeFrame': 'Up to end of study visit (90 days after the last dose)', 'description': 'Pharmacokinetics (PK) parameters'}, {'measure': 'Half-life of SOA101 (T1/2)', 'timeFrame': 'Up to end of study visit (90 days after the last dose)', 'description': 'Pharmacokinetics (PK) parameters'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Up to end of study visit (90 days after the last dose)', 'description': 'Evaluation of anti-tumor activity of SOA101'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '39234811', 'type': 'RESULT', 'citation': 'Lin YC, Chen MC, Huang SW, Chen Y, Ho JH, Lin FY, Tan XT, Chiang HC, Huang CC, Tu CY, Cho DY, Chiu SC. Targeting Dual Immune Checkpoints PD-L1 and HLA-G by Trispecific T Cell Engager for Treating Heterogeneous Lung Cancer. Adv Sci (Weinh). 2024 Nov;11(41):e2309697. doi: 10.1002/advs.202309697. Epub 2024 Sep 5.'}]}, 'descriptionModule': {'briefSummary': 'The investigational drug, SOA101, is a nanobody-based trispecific antibody T cell engager targeting PD-L1/HLA-G/CD3. This is a Phase I/IIa study including dose-escalation, dose optimization and dose expansion parts to exam safety, tolerability, pharmacokinetics, immunogenecity and efficacy of SOA101 on advanced or metastatic solid tumor treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years old.\n2. Subjects with locally advanced, or metastatic solid tumors confirmed histologically or cytologically as one of the following cancer types for whom no suitable alternative standard-of-care therapy exists:\n\n 1. Non-small cell lung cancer (NSCLC);\n 2. Ovarian cancer (OC);\n 3. Head and neck carcinoma (H\\&N);\n 4. Breast cancer (BC);\n 5. Colorectal cancer (CRC).\n3. Pathologically confirmed combined positive score (CPS) with ≥ 1% expression of PD-L1.\n4. At least one measurable lesion\n5. Adequate organ function\n6. Female subject must either not be of childbearing potential or a negative pregnancy test\n7. Non-vasectomized male subjects must practice highly effective contraception\n\nExclusion Criteria:\n\n1. Active bacterial, fungal, viral OR atypical infection requiring systemic medication.\n2. Received any investigational drug within 4 weeks before screening.\n3. Confirmed active HIV (without controlled disease on HAART), HBV, or HCV infection.\n4. Symptomatic, unstable central nervous system malignancy OR metastasis\n5. Have received organ or tissue transplantation or allogeneic cell therapies.\n6. Non-adequate cardiac function\n7. Known hypersensitivity to any anti-PD-L1 therapy or anti-CD3 therapy.'}, 'identificationModule': {'nctId': 'NCT07055594', 'acronym': 'NbTAST-01', 'briefTitle': 'A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shine-On Biomedical Co., Ltd.'}, 'officialTitle': 'A Phase I/IIa Dose-escalation, Dose-optimization and Dose Expansion Study to Evaluate the Safety and Preliminary Efficacy of Tri-specific Antibody (SOA101) in Subjects With Advanced Solid Tumors.', 'orgStudyIdInfo': {'id': 'SOA101-CL-Proto-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOA101', 'interventionNames': ['Drug: SOA101']}], 'interventions': [{'name': 'SOA101', 'type': 'DRUG', 'description': 'Participants will receive SOA101. The RP2D will be determined based on the results of the Phase I study. During the dose expansion phase, participants will receive SOA101 at the RP2D regimen.', 'armGroupLabels': ['SOA101']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shu-Ting Chuang', 'role': 'CONTACT', 'email': '008260@tool.caaumed.rg.tw', 'phone': '+886422052121'}], 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Jennifer Ho', 'role': 'CONTACT', 'email': 'rd005@shineon-bio.com', 'phone': '+886423272888'}, {'name': 'Oscar Yang', 'role': 'CONTACT', 'email': 'rd009@shineon-bio.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shine-On Biomedical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}