Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-04 @ 5:32 PM
Study NCT ID:
NCT06756035
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2024-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT-95 in Advanced Cancers Associated With Mesothelin Expression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2024-12-24', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the MTD or RD of CT-95 [Safety and Tolerability]', 'timeFrame': 'From date of first dose of CT-95 until 28 days following the first dose.', 'description': 'The frequency of dose-limiting toxicities (DLTs) will be analyzed along with safety and tolerability measures to determine the MTD or RD of CT-95.'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.', 'description': 'The frequency and severity of adverse events, serious adverse events, and adverse events of special interest will be analyzed.'}], 'secondaryOutcomes': [{'measure': 'Evaluate Response Rates [Anti-tumor Activity]', 'timeFrame': 'At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first', 'description': 'Overall response rates will be calculated using RECIST 1.1 (and mRECIST for patients with mesothelioma) for CT-95.'}, {'measure': 'Evaluate Progression-free Survival [Anti-tumor Activity]', 'timeFrame': 'At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.', 'description': 'PFS will be summarized using RECIST 1.1 (and mRECIST for patients with mesothelioma) for CT-95.'}, {'measure': 'Evaluate Overall Survival [Survival]', 'timeFrame': 'From the time of the first dose of CT-95 until approximately two years post-first dose.', 'description': 'Overall survival will be summarized for CT-95.'}, {'measure': 'Evaluate the Maximum Serum Concentration (Cmax) [Pharmacokinetics]', 'timeFrame': 'From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.', 'description': 'Serum concentrations of CT-95 analyzed as a function of time relative to dosing will be calculated.'}, {'measure': 'Evaluate the Area Under the Curve (AUC) [Pharmacokinetics]', 'timeFrame': 'From date of first dose of CT-95 for 5 months or treatment discontinuation, whichever comes first.', 'description': 'The AUC of CT-95 analyzed as a function of time relative to dosing will be calculated.'}, {'measure': 'Evaluate Anti-Drug Antibodies [Immunogenicity]', 'timeFrame': 'From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.', 'description': 'Incidence and titer of ADAs will be evaluated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phase 1 Dose Escalation Study', 'CT-95', 'Advanced, recurrent cancers', 'Unresectable, metastatic cancers', 'Cancers associated with mesothelin expression'], 'conditions': ['Mesothelin-Expressing Tumors', 'Epithelial Ovarian Cancer', 'Malignant Pleural Mesothelioma, Advanced', 'Malignant Peritoneal Mesothelioma, Advanced', 'Pancreatic Adenocarcinoma Advanced or Metastatic', 'Lung Adenocarcinoma Metastatic', 'Cholangiocarcinoma Advanced', 'Cholangiocarcinoma Non-resectable', 'Mesothelin-expressing Advanced Cancers', 'Mesothelin-positive Advanced Malignant Solid Tumors', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1a/1b open-label, dose escalation study to evaluate the safety and efficacy of CT-95 (study drug), a humanized T cell engaging bispecific antibody targeting Mesothelin, in subjects with advanced solid tumors associated with Mesothelin expression.', 'detailedDescription': 'The Phase 1a Dose Escalation portion of the trial will enroll subjects in one of approximately 8 dose escalation cohorts to assess the safety and tolerability of CT-95, as well as determine the maximum tolerated dose (MTD) or other recommended dose(s) for expansion (RDE\\[s\\]) for further study in 2 dose optimization cohorts. Subjects will receive CT-95 as a single agent administered once weekly (QW) intravenously (IV) over a 4-week cycle.\n\nThe Phase 1b Dose Expansion portion will evaluate CT-95 in indication-specific expansion cohorts'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ECOG 0 or 1\n* Subjects with evaluable disease per RECIST 1.1 or mRECIST\n* Subjects with adequate organ function.\n* Subjects with advanced cancers associated with mesothelin expression\n\nExclusion Criteria:\n\n* Uncontrolled significant active infection or any medical or other condition that in opinion of the investigator would preclude the subject's participation in the study.\n* Prior treatment with MSLN-targeted CD3 or chimeric antigen receptor T cell (CAR-T) therapy\n* Concurrent participation in another investigational clinical trial.\n* Evidence of leptomeningeal disease"}, 'identificationModule': {'nctId': 'NCT06756035', 'briefTitle': 'CT-95 in Advanced Cancers Associated With Mesothelin Expression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Context Therapeutics Inc.'}, 'officialTitle': 'Phase 1a/1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression', 'orgStudyIdInfo': {'id': 'CNTX-CT95-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-95', 'description': 'Each dose cohort will have weekly dosing. Anticipate approximately 8 dose cohorts.', 'interventionNames': ['Drug: CT-95']}], 'interventions': [{'name': 'CT-95', 'type': 'DRUG', 'description': 'Weekly IV dosing', 'armGroupLabels': ['CT-95']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Front Desk', 'role': 'CONTACT', 'email': 'CANN.DDUDenverGeneral@SarahCannon.com', 'phone': '720-754-2610'}], 'facility': 'Context Investigational Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cancer Clinical Trials', 'role': 'CONTACT', 'email': 'Cancerclinicaltrials@bsd.uchicago.edu', 'phone': '773-702-6233'}], 'facility': 'Context Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Spagnuolo', 'role': 'CONTACT', 'email': 'ashley.spagnuolo@startresearch.com', 'phone': '616-954-5552'}], 'facility': 'Context Investigational Site', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Oncology Clinical Research Referral Office', 'role': 'CONTACT', 'email': 'OncologyResearchReferral@hmhn.org', 'phone': '551-996-1777'}], 'facility': 'Context Investigational Site', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ask Phase1', 'role': 'CONTACT', 'email': 'AskPhase1@jefferson.edu', 'phone': '215-586-0199'}], 'facility': 'Context Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Cannon Research Institute', 'role': 'CONTACT', 'phone': '844-482-4812'}], 'facility': 'Context Investigational Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trial Navigator', 'role': 'CONTACT', 'email': 'jgeorg@nextoncology.com', 'phone': '210-580-9521'}], 'facility': 'Context Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Isabel Jimenez', 'role': 'CONTACT', 'email': 'isabel.jimenez@startresearch.com', 'phone': '210-593-5265'}, {'name': 'Christina Santana', 'role': 'CONTACT', 'email': 'csantana@startresearch.com', 'phoneExt': '210-593-5205'}], 'facility': 'Context Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Curtis Reinard', 'role': 'CONTACT', 'email': 'clinical@contexttherapeutics.com', 'phone': '267-225-7416'}], 'overallOfficials': [{'name': 'Karen Chagin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Context Therapeutics Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Context Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}