CLINICAL_TRIALS ClinicalTrials.gov record update

A 2-part Phase 1/2 Open-label Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ODM-212 in Combination With Anti-cancer Therapy in Participants With Advanced Solid Tumours

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT07563738
Title field or adapter rule: {'original_value': 'A 2-part Phase 1/2 Open-label Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ODM-212 in Combination With Anti-cancer Therapy in Participants With Advanced Solid Tumours', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:22.593717+00:00
Published At: 2026-10-22T00:00:00+00:00
Record Updated At: 2026-10-22
Source Retrieved At: 2026-10-31T22:17:25.750886+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: ["Mesothelioma", "Pancreatic Cancer", "NSCLC (Advanced Non-small Cell Lung Cancer)"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-10-22", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT07563738"
protocolSection.identificationModule.officialTitle: "A 2-part Phase 1/2 Open-label Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ODM-212 in Combination With Anti-cancer Therapy in Participants With Advanced Solid Tumours"
protocolSection.statusModule.overallStatus: "RECRUITING"
protocolSection.designModule.phases: ["PHASE1", "PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

{'armGroupLabels': ['ODM-212 with gemcitabine and nab-paclitaxel in PDAC', 'ODM-212 with ipilimumab/nivolumab in mesothelioma', 'ODM-212 with sotorasib in NSCLC'], 'description': 'ODM-212 40mg tablet', 'name': 'ODM-212', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['ODM-212 with ipilimumab/nivolumab in mesothelioma'], 'description': 'Ipilimumab: 1 mg/kg administered intravenously over 30 minutes every 6 weeks. Nivolumab: 360 mg administered intravenously over 30 minutes every 3 weeks.', 'name': 'Ipilimumab and nivolumab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['ODM-212 with gemcitabine and nab-paclitaxel in PDAC'], 'description': 'Nab-paclitaxel 125 mg/m2 administered intravenously over 30 minutes on Days 1, 8 and 15 of each 28-day cycle.\n\nGemcitabine 1000 mg/m2 administered intravenously over 30 minutes immediately after the completion of nab-paclitaxel administration on days 1, 8 and 15 of each 28-day cycle', 'name': 'Gemcitabine and nab-paclitaxel', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['ODM-212 with sotorasib in NSCLC'], 'description': 'Sotorasib total daily dose of 960 mg taken orally q.d. every day of the 21-day cycle', 'name': 'sotorasib', '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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