CLINICAL_TRIALS ClinicalTrials.gov record update

First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT04222413
Title field or adapter rule: {'original_value': 'First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:21.257914+00:00
Published At: 2026-10-30T00:00:00+00:00
Record Updated At: 2026-10-30
Source Retrieved At: 2026-10-31T22:18:26.854673+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: ["Advanced Solid Tumors", "Metastatic Pancreatic Cancer", "Pediatric Solid Tumor", "Advanced Breast Cancer", "Malignant Peripheral Nerve Sheath Tumor", "Colorectal Neoplasms"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-10-30", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT04222413"
protocolSection.identificationModule.officialTitle: "First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors"
protocolSection.statusModule.overallStatus: "RECRUITING"
protocolSection.designModule.phases: ["PHASE1"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

{'armGroupLabels': ['1/Arm 1', '2/Arm 2'], 'description': 'Phase IA: Loading dose on Day 1 of Cycle 1 for Dose Levels 1-7. Loading dose on Days 1 and 3 of Cycle 1 for Dose Levels 8-11. After the loading dose on Day 1 or Days 1 and 3 of Cycle 1, continue on Mondays-Wednesdays-Fridays of every following cycle. Phase IB: PO according to the dose and schedule estimated during Phase IA', 'name': 'Metarrestin', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

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

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