Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:40 PM
Study NCT ID:
NCT07407933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-12
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-06', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nature and Frequency with Dose-Limiting Toxicities (DLTs)', 'timeFrame': '21 days'}, {'measure': 'Adverse Events', 'timeFrame': 'First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years)', 'description': 'Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'DOR', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'PFS', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'OS', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'AUC', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'CL', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Vss', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 't1/2', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Cmax', 'timeFrame': 'Up to approximately 3 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Small cell lung cancer, Antibody drug conjugate, YL201, atezolizumab'], 'conditions': ['Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. The planned dose levels of YL201 are 1.2 mg/kg, 1.6 mg/kg and 2.0 mg/kg. Part 2 consists of a dose optimization stage followed by a dose expansion stage. During the dose optimization stage, participants will be randomized 1:1:1 to receive either YL201 at 1.2 mg/kg,1.6 mg/kg or 2.0 mg/kg Q3W in combination with fixed dose of atezolizumab. The decision to initiate the dose expansion stage in Part 2 and choose one or two of the YL201 dose level(s) will be based on the review of safety, PK, and efficacy from the dose optimization stage. Treatment will continue until disease progression, unacceptable toxicity, or withdraw of consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.18 years of age or older. 2. Histologically or cytologically confirmed diagnosis of ES-SCLC 3. Eastern Cooperative Oncology Group performance status of 0 or 1 4. Adequate hematologic and end-organ function\n\nExclusion Criteria:\n\n1. No prior systemic anti-cancer treatment for ES-SCLC\n2. No prior treatment targeting B7H3 or topoisomerase I inhibitor\n3. No clinically active brain metastases or spinal cord compression\n4. No current or history of interstitial lung disease (ILD)/ pneumonitis\n5. No clinically significant cardiovascular disease (eg, New York Heart Association class II to IV congestive heart failure)\n\nOther protocol-defined inclusion/ exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT07407933', 'briefTitle': 'A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'MediLink Therapeutics (Suzhou) Co., Ltd.'}, 'officialTitle': 'A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'YL201-INT-102-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W', 'interventionNames': ['Drug: YL201', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W', 'interventionNames': ['Drug: YL201', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W', 'interventionNames': ['Drug: YL201', 'Drug: Atezolizumab']}], 'interventions': [{'name': 'YL201', 'type': 'DRUG', 'description': 'YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.', 'armGroupLabels': ['YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W', 'YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W', 'YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'description': 'Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle', 'armGroupLabels': ['YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W', 'YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W', 'YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20057', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}], 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'centralContacts': [{'name': 'MediLink Study Team', 'role': 'CONTACT', 'email': 'clinicaltrials@medilinkthera.com', 'phone': '+86 0512-62858368'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MediLink Therapeutics (Suzhou) Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}