Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT07213804
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Two-Part Phase 3 Study of LY4170156 in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D010534', 'term': 'Peritoneal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D019772', 'term': 'Topotecan'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1080}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-10-07', 'studyFirstSubmitQcDate': '2025-10-07', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Randomization to radiographic progression or death from any cause (up to 70 months)', 'description': 'PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Randomization to date of death from any cause (up to 70 months)'}, {'measure': 'PFS', 'timeFrame': 'Randomization to radiographic progression or death from any cause (up to 70 months)', 'description': 'PFS by blinded independent central review (BICR)'}, {'measure': 'Overall Response Rate (ORR): Proportion of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'Randomization to disease progression or death (up to 70 months)', 'description': 'ORR per RECIST v1.1'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Date of first documented CR or PR to date of radiographic progression or death from any cause (up to 70 months)', 'description': 'DOR per RECIST v1.1'}, {'measure': 'Disease Control Rate (DCR): Proportion of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD)', 'timeFrame': 'Randomization to disease progression or death from any cause (up to 70 months)', 'description': 'DCR per RECIST v1.1'}, {'measure': 'PFS2', 'timeFrame': 'Randomization to disease progression on next line of treatment or death from any cause (up to 70 months)'}, {'measure': 'Time to Initiation of Subsequent Systemic Anticancer Therapy or Death', 'timeFrame': 'Randomization to initiation of subsequent systemic anticancer or death from any cause (up to 70 months)'}, {'measure': 'Proportion of Participants with Response of Cancer Antigen-125 (CA-125) per Gynecologic Cancer Intergroup Criteria (GCIG)', 'timeFrame': 'Randomization to 30 days post treatment discontinuation', 'description': 'Per GCIG'}, {'measure': 'Percentage of Assessments with High Side-effect Bother, as measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT GP5)', 'timeFrame': 'Randomization to 30 days post treatment discontinuation', 'description': 'FACT-GP5 is a single-item, patient-reported instrument for assessing overall treatment side-effect burden. High side effect bother is defined as a score of 3 or 4 on a 5-point Likert scale. Higher scores represent higher symptom burden.'}, {'measure': 'Change from Baseline in Abdominal/GI Symptoms, as measured by the European Organization for Research and Treatment of Cancer Ovarian Cancer Module (EORTC OV28)', 'timeFrame': 'Randomization to 30 days post treatment discontinuation', 'description': 'The EORTC OV28 consists of 28 items covering 3 functional scales and 5 symptom scales. The Abdominal/GI symptom scale ranges from 0 to 100. Higher scores indicate worse symptoms.'}, {'measure': 'Change from Baseline in Overall Health-related Quality of Life (HRQoL), as measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale', 'timeFrame': 'Randomization to 30 days post treatment discontinuation', 'description': 'The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional HRQoL in cancer patients. Overall HRQoL is measured by the EORTC QLQ-30 Global Health Status/Quality of Life Subscale (two items). Response options range from 0 - 100. Higher score represents better overall HRQoL.'}, {'measure': 'Pharmacokinetics (PK): Minimum Blood Plasma Concentration (Cmin) of LY4170156', 'timeFrame': 'Randomization through end of treatment (up to 70 months)]'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Folate Receptor Alpha', 'Antibody-drug Conjugate', 'Platinum-Resistant', 'Platinum-Sensitive', 'sofe-m'], 'conditions': ['Ovarian Neoplasms', 'Fallopian Tube Neoplasms', 'Peritoneal Neoplasms', 'Neoplasm Metastasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/660615', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "This is a clinical study that has two parts. It is testing a potential new medicine called LY4170156 for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based treatments (a type of chemotherapy). Part B looks at participants whose cancer still responds to platinum-based treatments. The researchers want to find out if LY4170156 works better than the usual treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPart A and B:\n\n* Have histologically confirmed high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.\n* Have confirmed availability of tumor tissue block or slides\n* Have radiographic progression on or after most recent line of systemic anticancer therapy\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Have measurable disease per RECIST v1.1\n\nPart A:\n\n* Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy.\n* Have previously received greater than or equal to (≥)1 but ≤3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior therapy is allowed if one of those lines is mirvetuximab soravtansine.\n* Have received prior bevacizumab treatment, unless documented contraindication or intolerance.\n* Have received treatment with a poly(ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance.\n\nPart B:\n\n* Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (\\>)6 months of their last administration of platinum therapy\n* Have previously received ≥1 but ≤2 prior lines of systemic cytotoxic chemotherapy\n* Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.\n\nExclusion Criteria:\n\nPart A and B:\n\n\\- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.\n\nPart A:\n\n\\- Have primary platinum-refractory disease, defined as disease that progressed ≤3 months since the last dose of first-line platinum-containing chemotherapy.\n\nPart B:\n\n\\- Have clinically significant proteinuria'}, 'identificationModule': {'nctId': 'NCT07213804', 'acronym': 'FRAmework-01', 'briefTitle': 'A Two-Part Phase 3 Study of LY4170156 in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'FRAmework-01: A Two-Part Phase 3 Study of LY4170156 Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and LY4170156 Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.', 'orgStudyIdInfo': {'id': '27727'}, 'secondaryIdInfos': [{'id': '2025-522255-25-00', 'type': 'CTIS'}, {'id': 'J5E-MC-JZXB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'GOG-3133', 'type': 'OTHER', 'domain': 'Gynecologic Oncology Group'}, {'id': 'ENGOT-ov97/GINECO-NOGGO', 'type': 'OTHER', 'domain': 'European Network of Gyneaecological Oncological Trial Groups'}, {'id': 'APGOT-OV17', 'type': 'OTHER', 'domain': 'Asia-Pacific Gynecologic Oncology Trials Group'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: LY4170156', 'description': 'Administered intravenously (IV).', 'interventionNames': ['Drug: LY4170156']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)', 'description': "Investigator's Choice of Chemotherapy or MIRV given IV.", 'interventionNames': ['Drug: Paclitaxel', 'Drug: Topotecan', 'Drug: Gemcitabine', 'Drug: Pegylated liposomal doxorubicin', 'Drug: MIRV']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: LY4170156 plus Bevacizumab', 'description': 'Administered IV.', 'interventionNames': ['Drug: LY4170156', 'Drug: Bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab', 'description': "Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.", 'interventionNames': ['Drug: Paclitaxel', 'Drug: Gemcitabine', 'Drug: Pegylated liposomal doxorubicin', 'Drug: Bevacizumab', 'Drug: Carboplatin']}], 'interventions': [{'name': 'LY4170156', 'type': 'DRUG', 'otherNames': ['sofetabart mipitecan'], 'description': 'Administered IV', 'armGroupLabels': ['Part A: LY4170156', 'Part B: LY4170156 plus Bevacizumab']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)', 'Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab']}, {'name': 'Topotecan', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)', 'Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab']}, {'name': 'Pegylated liposomal doxorubicin', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)', 'Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab']}, {'name': 'MIRV', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Part B: LY4170156 plus Bevacizumab', 'Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lyndsay Willmott', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HonorHealth', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '8187484726'}, {'name': 'Diana Pearre', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '93463', 'city': 'Solvang', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Bank', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sansum Clinic', 'geoPoint': {'lat': 34.59582, 'lon': -120.13765}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 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Bradford', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maine Medical Center - Scarborough Campus', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '21204', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Fong Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Greater Baltimore Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '4106019083'}, {'name': 'Pallavi Kumar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sinai Hospital Of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '508-334-1160'}, {'name': 'Susan Zweizig', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Massachusetts Chan Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Morris', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '269-382-2500'}, {'name': 'Anna Hoekstra', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West Michigan Cancer Center', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Saravut Weroha', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester, Minnesota', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '2012276200'}, {'name': 'Sharyn Lewin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Holy Name Medical Center', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen Finkelstein', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Optimum Clinical Research Group', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Veena John', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwell Health/ RJ Zuckerberg Cancer Center', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': 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