Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT07197827
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of YL242 in Subjects With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 424}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-09-26', 'studyFirstSubmitQcDate': '2025-09-26', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) in Participants With Advanced Solid Malignant Tumors (Part 2, and 4-6)', 'timeFrame': 'Approximately within 36 months', 'description': 'Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response \\[CR\\] or partial response \\[PR\\] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.'}, {'measure': 'Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Baseline up to 42 days post last patients last dose, approximately within 36 months', 'description': 'AEs will be collected systematically from signing of the informed consent form (ICF) through 42 days after last dose.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Serum Concentration Time Curve (AUC) of YL242', 'timeFrame': 'Approximately within 36 months'}, {'measure': 'Maximum Plasma Concentration (Cmax) of YL242', 'timeFrame': 'Approximately within 36 months'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of YL242', 'timeFrame': 'Approximately within 36 months'}, {'measure': 'Incidence of anti-YL242 antibody', 'timeFrame': 'Approximately within 36 months'}, {'measure': 'Terminal Elimination Half-life (t1/2) of Serum YL242', 'timeFrame': 'Approximately within 36 months'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Approximately within 36 months', 'description': 'Disease control rate (DCR) was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oncology', 'VEGF', 'Antibody drug conjugate', 'Developmental Phase I/II'], 'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with advanced solid malignant tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged ≥18 years.\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1\n* Adequate organ and bone marrow function\n* Tumor type:\n\nPart 1-3: Advanced/unresectable or metastatic solid malignant tumor; Have received at least one prior line of systemic anti-tumor therapy\n\nPart 4: locally advanced or metastatic non-sq NSCLC without AGA and HCC; Have not received any systemic anti-tumor therapy;\n\nPart 5: mCRC, have received at least one (5a) or one (5b) prior line of systemic anti-tumor therapy\n\nPart 6: advanced or metastatic HER2-negative G/GEJ; have received at least one (6a) or one (6b) prior line of systemic anti-tumor therapy\n\nExclusion Criteria:\n\n* Be intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor\n* Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases\n* Clinically significant concomitant pulmonary disease\n* A history of leptomeningeal carcinomatosis or carcinomatous meningitis\n* Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results"}, 'identificationModule': {'nctId': 'NCT07197827', 'briefTitle': 'A Study of YL242 in Subjects With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'MediLink Therapeutics (Suzhou) Co., Ltd.'}, 'officialTitle': 'A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 Monotherapy and Combinations in Advanced Solid Tumors.', 'orgStudyIdInfo': {'id': 'YL242-INT-101-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 and Part 2: Mono Dose Escalation & Expansion', 'description': 'Participants receive YL242 administered via intravenous (IV) solution per protocol defined dose level and frequency.', 'interventionNames': ['Drug: YL242']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 and 4: Combination Dose Escalation & Expansion', 'description': 'Participants receive YL242 at protocol defined dose level, in combination with Pembrolizumab (200 mg), administered via intravenous (IV) solution at protocol defined dose level and frequency.', 'interventionNames': ['Drug: YL242; Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 5: Combination Dose Optimization and Expansion', 'description': 'Participants receive YL242, 5-FU and LV, administered via intravenous (IV) solution.', 'interventionNames': ['Drug: YL242; 5-FU; LV']}, {'type': 'EXPERIMENTAL', 'label': 'Part 6: Combination Dose Optimization and Expansion', 'description': 'Participants receive YL242, pembrolizumab and 5-FU, administered via intravenous (IV) solution at protocol defined frequency.', 'interventionNames': ['Drug: YL242; Pembrolizumab; 5-FU']}], 'interventions': [{'name': 'YL242', 'type': 'DRUG', 'description': 'The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes.', 'armGroupLabels': ['Part 1 and Part 2: Mono Dose Escalation & Expansion']}, {'name': 'YL242; Pembrolizumab', 'type': 'DRUG', 'description': 'The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes. Pembrolizumab will be administered subsequent to YL242.', 'armGroupLabels': ['Part 3 and 4: Combination Dose Escalation & Expansion']}, {'name': 'YL242; 5-FU; LV', 'type': 'DRUG', 'description': 'The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes.\n\nLV and 5-FU will be sequentially administered following YL242.', 'armGroupLabels': ['Part 5: Combination Dose Optimization and Expansion']}, {'name': 'YL242; Pembrolizumab; 5-FU', 'type': 'DRUG', 'description': 'The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. YL242 will be administered via Intravenous (IV) Infusion.\n\nPembrolizumab and 5-FU will be administered in sequence after YL242.', 'armGroupLabels': ['Part 6: Combination Dose Optimization and Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'US-201', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'US-202', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'US-204', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'US-206', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'US-205', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'US-203', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'US-207', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '2170', 'city': 'Liverpool', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'AUS-101', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'AUS-102'}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'AUS-104', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'AUS-103', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'AUS-105', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'CN-303', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'CN-301', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'study coordinator', 'role': 'CONTACT'}], 'facility': 'CN-302', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Medilink Study Team', 'role': 'CONTACT', 'email': 'clinicaltrials@medilinkthera.com', 'phone': '+86 0512-62858368'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MediLink Therapeutics (Suzhou) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}