Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-07 @ 9:48 AM
Study NCT ID:
NCT06239194
Status:
RECRUITING
Last Update Posted:
2025-06-22
First Post:
2024-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine 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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2024-01-18', 'studyFirstSubmitQcDate': '2024-01-26', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All Phases: Adverse events (AEs)', 'timeFrame': 'Baseline until end of study, up to approximately 9 months', 'description': 'Incidence and severity of AEs and serious AEs (SAEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 including changes in clinical laboratory parameters'}, {'measure': 'Phase 1b and Phase 2a: Objective response rate of MDX2001', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 6 months', 'description': 'Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.'}, {'measure': 'Phase 1: Recommended Phase 2 dose (RP2D)', 'timeFrame': 'Baseline until end of study, up to approximately 9 months', 'description': 'Recommended Phase 2 dose is determined following the evaluation of MDX2001 safety including the incidences of dose limiting toxicities (DLTs), MDX2001 anti-tumor activity, and MDX2001 pharmacokinetics'}], 'secondaryOutcomes': [{'measure': 'Phase 1a: Objective response rate of MDX2001', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 6 months', 'description': 'Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per RECIST v1.1.'}, {'measure': 'All Phases: Duration of response (DOR)', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 6 months', 'description': 'Duration of response is defined as the time from first documentation of response (complete response \\[CR\\] or partial response \\[PR\\]) to documentation of objective disease progression or death due to any cause, whichever occurs first'}, {'measure': 'All Phases: Time to response (TTR)', 'timeFrame': 'From date of enrollment until the first documentation of response (CR or PR), approximately 4 months', 'description': 'Time to response is defined as the time from first dose to first documentation of response (CR or PR)'}, {'measure': 'All Phases: Disease control rate (DCR)', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 6 months', 'description': 'Disease control rate is defined as the proportion of evaluable patients with a best overall response (BOR) of stable disease, CR or PR'}, {'measure': 'All Phases: Progression free survival (PFS)', 'timeFrame': 'From date of enrollment until the end of treatment, up to approximately 6 months', 'description': 'Progression-free survival is defined as the time from the first dose to the date of disease progression or death (any cause), whichever occurs first'}, {'measure': 'All Phases: Pharmacokinetic Parameter Cmax of MDX2001', 'timeFrame': 'From date of enrollment until completion of the 6th cycle of treatment, up to approximately 6 months', 'description': 'Maximum observed plasma concentration'}, {'measure': 'All Phases: Pharmacokinetic parameter area under the curve (AUC(0-T)) of MDX2001', 'timeFrame': 'From date of enrollment until the completion of the 3rd cycle of treatment, up to approximately 3 months', 'description': 'Area under the plasma concentration versus time curve'}, {'measure': 'All Phases: Evaluation of MDX2001 immunogenicity', 'timeFrame': 'Baseline until end of study, up to approximately 9 months', 'description': 'The presence and persistence of anti-MDX2001 antibodies'}, {'measure': 'All Phases: Correlation between tumor antigen expression and anti-tumor activity of MDX2001', 'timeFrame': 'Baseline until the end of treatment, up to approximately 6 months', 'description': 'Relationship between H score cell surface target protein expression in tumor tissue at baseline and objective responses with MDX2001'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Tract Cancer', 'Breast Cancer', 'Cervical Cancer', 'Colon Cancer', 'Endometrial Cancer', 'Esophageal Cancer', 'Gastric Cancer', 'GastroEsophageal Cancer', 'Head and Neck Cancer', 'Hepatocellular Cancer', 'Non-small Cell Lung Cancer', 'Pancreatic Cancer', 'Prostate Cancer', 'Rectal Cancer', 'Renal Cancer', 'Thyroid Cancer']}, 'descriptionModule': {'briefSummary': 'This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.', 'detailedDescription': 'This study consists of Phase 1a dose escalation, Phase 1b dose expansion in a single indication, and Phase 2a expansion in a single indication.\n\nPrimary Objectives\n\n* All Phases: Evaluate the safety and tolerability of MDX2001 in patients with advanced solid tumor malignancies\n* Phase 1 only: Identify a recommended Phase 2 dose (RP2D) for further development of MDX2001\n* For Phase 1b and Phase 2: Assess the anti-tumor efficacy of MDX2001 in patients with selected advanced solid tumor malignancies\n\nSecondary Objectives:\n\n* Further characterize the anti-tumor activity of MDX2001 based on additional assessments of clinical benefit\n* Characterize the pharmacokinetics of MDX2001\n* Characterize the immunogenicity of MDX2001\n* Characterize relationship of baseline target protein expression in tumor tissue and clinical benefit\n\nThe expected duration of study intervention for patients may vary, based on progression date. The median expected duration of study per patient is estimated to be 10 months (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for long term follow-up).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age\n* Histologically or cytologically confirmed diagnosis of metastatic solid tumors\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* All patients should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.\n* All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Adequate hematologic, hepatic and renal function\n* Capable of giving signed informed consent\n\nExclusion Criteria:\n\n* Any clinically significant cardiac disease\n* Unresolved toxicities from previous anticancer therapy\n* Prior solid organ or hematologic transplant\n* Known untreated, active, or uncontrolled brain metastases\n* Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infectious requiring intravenous treatment.\n* Receipt of a live-virus vaccination within 28 days of planned treatment start\n* Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.\n* Participation in a concurrent clinical study in the treatment period.\n* Known hypersensitivity to MDX2001 or any of its ingredients\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT06239194', 'briefTitle': 'Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'ModeX Therapeutics, An OPKO Health Company'}, 'officialTitle': 'A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'MDX-2001-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1a - MDX2001 Dose Escalation', 'description': 'Patients with metastatic solid tumors will receive MDX2001 as intravenous (IV) infusion.', 'interventionNames': ['Drug: MDX2001']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b - Dose Expansion - Dose A', 'description': 'Patients with a single tumor indication receive MDX2001 as intravenous (IV) infusion.', 'interventionNames': ['Drug: MDX2001']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b - Dose Expansion - Dose B', 'description': 'Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion.', 'interventionNames': ['Drug: MDX2001']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2a - Cohort Expansion', 'description': 'Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion at the recommended Phase 2 dose.', 'interventionNames': ['Drug: MDX2001']}], 'interventions': [{'name': 'MDX2001', 'type': 'DRUG', 'description': 'MDX2001 intravenous infusion', 'armGroupLabels': ['Phase 1a - MDX2001 Dose Escalation', 'Phase 1b - Dose Expansion - Dose A', 'Phase 1b - Dose Expansion - Dose B', 'Phase 2a - Cohort Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Henry, MD', 'role': 'CONTACT'}], 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jaime R Merchan, MD', 'role': 'CONTACT', 'email': 'jmerchan2@med.miami.edu', 'phone': '305-243-2647'}], 'facility': 'Sylvester Comprehensive Cancer Center - University of Miami Health System', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Heist, MD, MPH', 'role': 'CONTACT', 'email': 'rheist@partners.org', 'phone': '617-724-4000'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Johnson, MD', 'role': 'CONTACT'}], 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ecaterina Dumbrava, MD', 'role': 'CONTACT'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Sommerhalder, MD', 'role': 'CONTACT'}], 'facility': 'NEXT Oncology', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Email recommended', 'role': 'CONTACT', 'email': 'info@modextx.com', 'phone': '(857) 233-9936'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ModeX Therapeutics, An OPKO Health Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}