Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-28 @ 5:08 AM
Study NCT ID:
NCT07076550
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098943', 'term': 'Uveal Melanoma'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D014604', 'term': 'Uveal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-07-11', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine max tolerated dose and recommended Phase 2 Dose', 'timeFrame': 'First 28 days following first study treatment', 'description': 'Rate of DLTs per dose level/cohort'}, {'measure': 'Incidence of treatment-related adverse events', 'timeFrame': 'From first study treatment until end of treatment', 'description': 'Rate and severity of suspected treatment-related adverse events, change from baseline laboratory values and change from baseline vital signs as graded by CTCAE version 5.0'}], 'secondaryOutcomes': [{'measure': 'Evaluate the preliminary efficacy of [225Ac]Ac-A9-3408 by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)', 'timeFrame': 'Up to 1 year from enrollment', 'description': 'Percent of patients who achieve an overall response (ORR), defined as the percent of patients who achieve a complete response (CR) or partial response (PR) by RECIST v1.1'}, {'measure': 'Evaluate biodistribution and normal organ dosimetry of [225Ac]Ac-A9-3408', 'timeFrame': 'Up to 7 days following each cycle (42 days)', 'description': 'Absorbed radiation dose estimates (Gy) in normal organs for \\[225Ac\\]Ac-A9-3408'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic Melanoma', 'Melanoma', 'Radiopharmaceuticals', 'Theranostic'], 'conditions': ['Melanoma Metastatic', 'Uveal Melanoma, Metastatic', 'Mucosal Melanoma']}, 'descriptionModule': {'briefSummary': "The goal of this trial is to see if this investigational drug is safe for adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery. It will also see if this investigational drug can shrink melanoma tumors in the body. The main questions this study aims to answer are:\n\n* What are the side effects of this investigational drug?\n* What is the highest dose of this investigational drug that can be given safely?\n\nParticipants will:\n\n* Take the investigational drug once every 6 weeks, for up to 6 times in total\n* Visit a doctor's office on a regular basis for checkups and tests", 'detailedDescription': 'This is a multicenter, open-label Phase 1-1b study of \\[225Ac\\]Ac-A9-3408 in subjects with unresectable or metastatic melanoma.\n\nThe primary aim of the Phase 1 portion of the study is to evaluate the safety and tolerability as well as the normal organ and tumor dosimetry of \\[225Ac\\]Ac-A9-3408 and to select a recommended Phase 2 dose (RP2D).\n\nThe aim of Phase 1b will be to evaluate the safety, efficacy, and normal organ and tumor dosimetry of \\[225Ac\\]Ac-A9-3408 administered at the RP2D in subjects with unresectable or metastatic cutaneous melanoma who had confirmed disease progression while receiving an anti-PD-1/PD-L1-containing regimen.\n\nThe interventional diagnostic \\[68Ga\\]Ga-A9T-3202 will be administered intravenously (IV) once during screening.\n\nThe interventional drug \\[225Ac\\]Ac-A9-3408 will be administered intravenously (IV) once every 6 weeks, for a total of up to 6 cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide written informed consent\n* \\[68Ga\\]Ga-A9T-3202 uptake in at least one measurable lesion (per RECIST v1.1) on PET scan\n* Histologically or cytologically confirmed unresectable or metastatic melanoma with disease progression on prior standard of care therapy\n* Adequate ECOG performance status\n* Adequate baseline organ function within 14 days of first dose of investigational product\n* Recovered from side effects of prior anticancer therapy\n* Women of childbearing potential (WOCBP) must have a negative pregnancy test and follow adequate birth control method(s) during the treatment period and for at least 6 months after last dose of \\[225Ac\\]Ac-A9-3408. Sexually active males with partners who are WOCBP must agree to adequate birth control method(s) during the treatment period and for at least 3 months after last dose of \\[225Ac\\]Ac-A9-3408\n\nExclusion Criteria:\n\n* Previous treatment with radioactive nuclides except radioactive imaging tracers\n* Treatment with another investigational product shortly prior to first dose of \\[225Ac\\]Ac-A9-3408 with exception of anti-PD-1/PD-L1 agents.\n* Concurrent anticancer therapy\n* Major surgery within 4 weeks of first dose of investigational product\n* Second malignancy within 2 years\n* Active, clinically serious infection\n* Known infusion reactions to components of the investigational product\n* Other clinically serious health conditions including cardiovascular and or severe infectious diseases\n* Significant central nervous system metastatic disease\n* Pregnant, breastfeeding or unwilling to practice adequate birth control method(s)\n* Any condition per the opinion of the investigator that would impact the safety of the subject, protocol adherence or ability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07076550', 'briefTitle': 'A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alpha-9 Oncology USA Inc.'}, 'officialTitle': 'A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of [225Ac]Ac-A9-3408 in Subjects With Unresectable or Metastatic Melanoma', 'orgStudyIdInfo': {'id': 'A9-3408-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1 Dose Escalation', 'description': 'Participants enrolled in Dose Escalation will receive a single dose of the investigational diagnostic agent \\[68Ga\\]Ga-A9T-3202 during screening, and receive the investigational treatment \\[225Ac\\]Ac-A9-3408 once every 6 weeks, for up to 6 total cycles.', 'interventionNames': ['Drug: [225Ac]Ac-A9-3408', 'Diagnostic Test: [68Ga]Ga-A9T-3202']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1B Dose Expansion', 'description': 'Participants enrolled in Dose Expansion will receive a single dose of the investigational diagnostic agent \\[68Ga\\]Ga-A9T-3202 during screening, and receive the investigational treatment \\[225Ac\\]Ac-A9-3408 once every 6 weeks, for up to 6 total cycles.', 'interventionNames': ['Drug: [225Ac]Ac-A9-3408', 'Diagnostic Test: [68Ga]Ga-A9T-3202']}], 'interventions': [{'name': '[225Ac]Ac-A9-3408', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Phase 1 Dose Escalation', 'Phase 1B Dose Expansion']}, {'name': '[68Ga]Ga-A9T-3202', 'type': 'DIAGNOSTIC_TEST', 'description': 'Administered IV', 'armGroupLabels': ['Phase 1 Dose Escalation', 'Phase 1B Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Dr. Malaka Ameratunga', 'role': 'CONTACT', 'email': 'M.Ameratunga@alfred.org.au', 'phone': '+61390763129'}], 'facility': 'Alfred Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6150', 'city': 'Murdoch', 'state': 'Western Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Dr. Zeyad Al-Ogaili', 'role': 'CONTACT', 'email': 'zeyad.al-ogaili@health.wa.gov.au', 'phone': '+61426824336'}], 'facility': 'Fiona Stanley Hospital', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}, {'zip': '6150', 'city': 'Murdoch', 'state': 'Western Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Prof Joe Cardaci', 'role': 'CONTACT', 'email': 'joe.cardaci@genesiscare.com', 'phone': '+610893661500'}], 'facility': 'GenesisCare Murdoch', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}], 'centralContacts': [{'name': 'Sam Vohra', 'role': 'CONTACT', 'email': 'sam@avionmedical.com.au', 'phone': '+61 300 131 548'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alpha-9 Oncology USA Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}