Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-29 @ 8:06 AM
Study NCT ID:
NCT05865535
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2023-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}], 'ancestors': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2023-05-09', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immunogenicity', 'timeFrame': 'From first dose to the last follow-up visit approximately 60-days post dose.', 'description': 'Serum levels of Anti-Drug Antibody (ADA) against AV-380 and their potential relationship with AEs and serum levels of GDF-15'}, {'measure': 'Weight', 'timeFrame': 'From enrollment to the last follow-up visit approximately 60-days post dose.', 'description': 'Change from baseline body weight during the study'}, {'measure': 'Patient-Reported Outcomes', 'timeFrame': 'From enrollment to the end of treatment, approximately 4 months', 'description': 'Change from baseline in the following questionnaires: Functional Assessment of Anorexia Cachexia Therapy (FAACT); Patient global impression of severity (PGI-S) and patient global impression of change (PGI-C) for appetite, fatigue, and physical activity.'}, {'measure': 'Lumbar (L3) Skeletal Muscle Index (L3SMI)', 'timeFrame': 'From enrollment to the end of treatment, approximately 4 months', 'description': 'Measurement of a cross-sectional area of muscle at the level of the third lumbar vertebra (L3) using computed tomography (CT) scan'}, {'measure': 'Physical Function', 'timeFrame': 'From enrollment to the end of treatment, approximately 4 months', 'description': 'Change from baseline in physical function endpoints, including Short Physical Performance Battery test and digital measures of non-sedentary time'}, {'measure': 'Serum level of GDF-15', 'timeFrame': 'From enrollment to the last follow-up visit approximately 60-days post dose.'}, {'measure': 'Albumin and CRP', 'timeFrame': 'From enrollment to the last follow-up visit approximately 60-days post dose.', 'description': 'Change from baseline in albumin and CRP levels'}, {'measure': 'Tumor status', 'timeFrame': 'From enrollment to the last follow-up visit approximately 60-days post dose.', 'description': 'Evaluate the effect of AV-380 on tumor burden and tumor status, per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)'}, {'measure': 'Biomarkers', 'timeFrame': 'From first dose to the last follow-up visit approximately 60-days post dose.', 'description': 'including activin A and cytokine levels (e.g., monocyte chemoattractant protein-1 \\[MCP-1\\] and proinflammatory)'}], 'primaryOutcomes': [{'measure': 'Assessment of adverse events (AEs)', 'timeFrame': 'From enrollment to the last follow-up visit approximately 60-days post dose', 'description': 'AEs as characterized by incidence, type, frequency, and severity (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\])'}, {'measure': 'Toxicity', 'timeFrame': 'While receiving study drug (up to 4 months)', 'description': 'Dose-limiting Toxicity (DLT) events observed at increasing doses of AV-380'}, {'measure': 'Laboratory Abnormalities', 'timeFrame': 'From enrollment to the last follow-up visit approximately 60-days post dose.', 'description': 'Laboratory abnormalities as characterized by type, frequency, severity (graded according to NCI-CTCAE v5.0) and timing.'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'From first dose to the last follow-up visit approximately 60-days post dose.', 'description': 'Maximum observed plasma concentration for AV-380'}, {'measure': 'Tmax', 'timeFrame': 'From first dose to the last follow-up visit approximately 60-days post dose', 'description': 'Time to reach the Cmax for AV-380'}, {'measure': 'AUC(0-t)', 'timeFrame': 'From first dose to the last follow-up visit approximately 60-days post dose.', 'description': 'Area under the plasma concentration-time curve from zero time to the last measurable point for AV-380'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cachexia']}, 'descriptionModule': {'briefSummary': 'This open label ascending dose study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AV-380 in cancer patients with Cachexia. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient must be ≥ 18 years of age at the time of signing the informed consent.\n2. Patients with histologically confirmed solid tumor cancer who are actively receiving SoC therapy for this cancer.\n3. Patients with cachexia as defined by Fearon criteria:\n\n 1. Weight loss \\> 5% over past 6 months (in absence of simple starvation), or\n 2. BMI \\< 20 kg/m2 and any degree of weight loss \\> 2%, or\n 3. Sarcopenia and any degree of weight loss \\> 2%\n4. Patients with life expectancy ≥ 3 months\n\nExclusion Criteria:\n\n1. History of allergic or anaphylactic reaction to any monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody\n2. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 2 weeks before first dose of study treatment.\n3. Myocardial infarction or heart failure of New York Heart Association Grade 3-4 within 3 months prior to start of protocol therapy\n4. Uncontrolled pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n5. Cachexia is caused by other reasons (e.g., severe chronic obstructive pulmonary disease, heart failure, or HIV/AIDS), or the patient has uncontrolled reversible causes of reduced oral food intake, including, but not limited to, oral mucositis, nausea/vomiting, diarrhea, and/or obstruction, impairing the patient's ability to eat as determined by the Investigator.\n6. Patients receiving tube feedings or parenteral nutrition at the time of Screening."}, 'identificationModule': {'nctId': 'NCT05865535', 'briefTitle': 'A Dose Escalation Study of AV-380 in Cancer Patients With Cachexia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AVEO Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1B Dose Escalation Study of AV-380 in Combination With Standard of Care Chemotherapy in Metastatic Cancer Patients With Cachexia and Elevated GDF-15 Levels', 'orgStudyIdInfo': {'id': 'AV-380-22-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Cohorts', 'description': 'Experimental: Dose escalation cohorts of AV-380 administered by IV infusion', 'interventionNames': ['Biological: AV-380']}], 'interventions': [{'name': 'AV-380', 'type': 'BIOLOGICAL', 'description': 'AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.', 'armGroupLabels': ['Dose Escalation Cohorts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Beverly Hills Cancer Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90712', 'city': 'Lakewood', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cancer and Blood Specialty Clinic', 'geoPoint': {'lat': 33.85363, 'lon': -118.13396}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hoag Memorial Hospital', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Advent Health Orlando Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Nebraska Cancer Specialists', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08816', 'city': 'East Brunswick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Astera Cancer Care', 'geoPoint': {'lat': 40.42788, 'lon': -74.41598}}, {'zip': '11967', 'city': 'Shirley', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'New York Cancer And Blood Specialists', 'geoPoint': {'lat': 40.80149, 'lon': -72.8676}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MUSC Hollings Cancer Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanderbilt University Henry-Joyce Cancer Clinic', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77339', 'city': 'Kingwood', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Community Clinical Trials', 'geoPoint': {'lat': 30.05691, 'lon': -95.18349}}], 'centralContacts': [{'name': 'AVEO Clinical Trials Office', 'role': 'CONTACT', 'email': 'clinical@aveooncology.com', 'phone': '(857)400-0101'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AVEO Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}