CLINICAL_TRIALS ClinicalTrials.gov record update

A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT07287917
Title field or adapter rule: {'original_value': 'A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:30.797489+00:00
Published At: 2026-10-22T00:00:00+00:00
Record Updated At: 2026-10-22
Source Retrieved At: 2026-10-31T22:18:24.976182+00:00
Timestamp Basis: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

protocolSection.conditionsModule.conditions: ["Melanoma (Skin Cancer)", "HER2-low Hormone Receptor Positive Breast Cancer"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-10-22", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT07287917"
protocolSection.identificationModule.officialTitle: "A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies"
protocolSection.statusModule.overallStatus: "RECRUITING"
protocolSection.designModule.phases: ["PHASE1", "PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

{'armGroupLabels': ['Arm 1: Breast Cancer (ER+ HER2-)', 'Arm 2: Melanoma'], 'description': 'Formulation: Enteric-coated oral tablet (100 mg base)\n\nDose: Body-surface-area-adjusted; starting dose = 300 mg PO BID; may escalate per 3 + 3 design\n\nAdministration: By mouth on an empty stomach (AM and PM doses)', 'name': 'AMXT 1501 Dicaprate', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Arm 1: Breast Cancer (ER+ HER2-)', 'Arm 2: Melanoma'], 'description': 'Formulation: 500 mg gel capsule\n\nDose: 500 mg PO once or twice daily, per cohort dose level', 'name': 'DFMO', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Arm 1: Breast Cancer (ER+ HER2-)'], 'description': 'Dose: 500 mg IM injection on Day 2 and Day 15 of Cycle 1, then Day 2 of each subsequent 28-day cycle', 'name': 'Fulvestrant', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Arm 1: Breast Cancer (ER+ HER2-)'], 'description': 'Dose: 400 mg PO BID for 4 days on / 3 days off each week (28-day cycle)', 'name': 'Capivasertib', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Arm 2: Melanoma'], 'description': '200 mg IV infusion every 3 weeks (Q3W) for up to 12 months', 'name': 'Pembrolizumab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

A recorded drug name is not by itself an indication or a condition-specific relationship.

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