Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-15 @ 3:02 PM
Study NCT ID:
NCT06422520
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707970', 'term': 'tislelizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-05-15', 'studyFirstSubmitQcDate': '2024-05-15', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Approximately 24 months', 'description': 'Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \\[NCI-CTCAE v 5.0\\]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria'}, {'measure': 'Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-C354', 'timeFrame': 'Approximately 1 month', 'description': 'Defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively'}, {'measure': 'Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-C354', 'timeFrame': 'Approximately 24 months', 'description': 'The potential RDFE(s) of BGB-C354 will be determined based on the MTD or MAD, taking into consideration the long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available'}, {'measure': 'Phase 1b: Overall Response Rate (ORR)', 'timeFrame': 'Approximately 24 months', 'description': 'ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).'}, {'measure': 'Phase 1b: Recommended Phase 2 dose (RP2D) of BGB-C354 alone and in combination with tislelizumab', 'timeFrame': 'Approximately 24 months', 'description': 'The RP2D of BGB-C354 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.'}], 'secondaryOutcomes': [{'measure': 'Phase 1a: ORR', 'timeFrame': 'Approximately 24 months', 'description': 'ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Approximately 24 months', 'description': 'DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Approximately 24 months', 'description': 'DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease as determined from tumor assessments by the investigator using RECIST v1.1.'}, {'measure': 'Phase 1b: Progression Free Survival (PFS)', 'timeFrame': 'Approximately 24 months', 'description': 'PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first as determined from tumor assessments by the investigator using RECIST v1.1.'}, {'measure': 'Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events', 'timeFrame': 'Approximately 24 months', 'description': 'Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \\[NCI-CTCAE v 5.0\\]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limitingtoxicity (DLT) criteria'}, {'measure': 'Maximum observed plasma concentration (Cmax) for BGB-C354', 'timeFrame': 'Twice in the first 3 months'}, {'measure': 'Minimum observed plasma concentration (Cmin) for BGB-C354', 'timeFrame': 'Approximately 12 months'}, {'measure': 'Time to maximum plasma concentration (Tmax) for BGB-C354', 'timeFrame': 'Twice in the first 3 months'}, {'measure': 'Half-life (t1/2) for BGB-C354', 'timeFrame': 'Twice in the first 3 months'}, {'measure': 'Area under the concentration-time curve (AUC) for BGB-C354', 'timeFrame': 'Twice in the first 3 months'}, {'measure': 'Apparent clearance (CL/F) for BGB-C354', 'timeFrame': 'Approximately 12 months'}, {'measure': 'Apparent volume of distribution (Vz/F) for BGB-C354', 'timeFrame': 'Approximately 12 months'}, {'measure': 'Accumulation ratio for BGB-C354', 'timeFrame': 'Approximately 12 months'}, {'measure': 'Number of participants with anti-drug antibodies (ADAs) to BGB-C354', 'timeFrame': 'Approximately 12 months'}, {'measure': 'Serum concentration of BGB-C354', 'timeFrame': 'Approximately 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BGB-C354', 'Tislelizumab', 'First-in-human', 'Advanced solid tumor', 'Anti-PD-1 Monoclonal Antibody', 'B7H3', 'antibody drug conjugate'], 'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors.\n\nStudy details include:\n\n* The study will be conducted in 2 phases: Phase 1a (Monotherapy Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).\n* The visit frequency will be approximately every 21 days during study treatment. Maximum treatment duration will be up to two years.\n* The study duration is estimated to be approximately 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n3. Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancer is not amenable to therapy with curative intent:\n4. ≥ 1 measurable lesion per RECIST v1.1.\n5. Able to provide an archived tumor tissue sample.\n6. Adequate organ function.\n7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s).\n8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).\n\nExclusion Criteria:\n\n1. Prior treatment with B7H3-targeted therapy.\n2. For Part B and Phase 1b: Prior treatment with antibody drug conjugates (ADCs) with topoisomerase I inhibitor payload (for Phase 1b, unless otherwise specified for specific cohorts).\n3. Participants with spinal cord compressions, active leptomeningeal disease or uncontrolled, or untreated brain metastasis\n4. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n5. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \\< 92%, or requirement for supplemental oxygen at baseline\n6. Uncontrolled diabetes, or \\> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium levels despite standard medical management ≤ 14 days before the first dose of study drug(s).\n7. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06422520', 'briefTitle': 'A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'BeOne Medicines'}, 'officialTitle': 'A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'BGB-C354-101'}, 'secondaryIdInfos': [{'id': '2024-513280-11-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1a: Part A (Monotherapy Dose Escalation)', 'description': 'BGB-C354 monotherapy doses at sequentially increasing levels.', 'interventionNames': ['Drug: BGB-C354']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1a: Part B (Safety Expansion)', 'description': 'Participants will enroll at safe dose levels recommended by the Safety Monitoring Committee (SMC) for further evaluation.', 'interventionNames': ['Drug: BGB-C354']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b: Part C (Monotherapy Expansion)', 'description': 'BGB-C354 will be administered at the recommended dose for expansion (RDFE).', 'interventionNames': ['Drug: BGB-C354']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b: Part D (Combination Therapy Expansion)', 'description': 'BGB-C354 and tislelizumab will be adminsitered at doses determined by the SMC.', 'interventionNames': ['Drug: BGB-C354', 'Drug: Tislelizumab']}], 'interventions': [{'name': 'BGB-C354', 'type': 'DRUG', 'description': 'Administered by intravenous infusion', 'armGroupLabels': ['Phase 1a: Part A (Monotherapy Dose Escalation)', 'Phase 1a: Part B (Safety Expansion)', 'Phase 1b: Part C (Monotherapy Expansion)', 'Phase 1b: Part D (Combination Therapy Expansion)']}, {'name': 'Tislelizumab', 'type': 'DRUG', 'description': 'Administered by intravenous infusion', 'armGroupLabels': ['Phase 1b: Part D (Combination Therapy Expansion)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32827-7400', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Florida Cancer Specialist Research Institute Lake Nona', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '02215-5418', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110-1010', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Next Oncology', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The University of Texas Md Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'NSW 2145', 'city': 'Westmead', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': 'VIC 3065', 'city': 'Fitzroy', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'St Vincents Hospital Melbourne', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': 'VIC 3004', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'WA 6009', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'One Clinical Research', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'status': 'COMPLETED', 'country': 'China', 'facility': 'Guangxi Medical University Cancer Hospital', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '430079', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Hubei Cancer Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Jilin Cancer Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '110042', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Liaoning Cancer Hospital and Institute', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'clinicaltrials@beigene.com', 'phone': '1.877.828.5568'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BeiGene'}]}, 'ipdSharingStatementModule': {'url': 'https://beigene.com/science/clinical-trials/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'See plan description', 'ipdSharing': 'YES', 'description': 'BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.\n\nBeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.\n\nQualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.', 'accessCriteria': 'See plan description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BeiGene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}