CLINICAL_TRIALS ClinicalTrials.gov record update

A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 Administered as Monotherapy or in Combination With Nivolumab or Standard of Care in Patients With Locally Advanced or Metastatic Solid Tumors

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT04396821
Title field or adapter rule: {'original_value': 'A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 Administered as Monotherapy or in Combination With Nivolumab or Standard of Care in Patients With Locally Advanced or Metastatic Solid Tumors', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:24.707221+00:00
Published At: 2026-09-29T00:00:00+00:00
Record Updated At: 2026-09-29
Source Retrieved At: 2026-10-31T22:17:54.613222+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 Cancer", "Gastric Cancer", "Gastroesophageal-junction Cancer", "Pancreatic Cancer"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-09-29", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT04396821"
protocolSection.identificationModule.officialTitle: "A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 Administered as Monotherapy or in Combination With Nivolumab or Standard of Care in Patients With Locally Advanced or Metastatic Solid Tumors"
protocolSection.statusModule.overallStatus: "ACTIVE_NOT_RECRUITING"
protocolSection.designModule.phases: ["PHASE1", "PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

{'armGroupLabels': ['Part A Q2W', 'Part A Q3W', 'Part B Cohort A', 'Part B Cohort B', 'Part B Cohort C'], 'description': 'TST001 is a humanized IgG1 monoclonal antibody.', 'name': 'TST001', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Part B Cohort A', 'Part B Cohort B'], 'description': 'Nivolumab is one of the PD-1 checkpoint inhibitors, and has proved clinical benefit for multiple late-stage malignancies', 'name': 'Nivolumab Injection [Opdivo]', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Part B Cohort A'], 'description': 'mFOLFOX6 is a combination chemotherapy regimen including the drugs leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin.', 'name': 'mFOLFOX6', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Part B Cohort C'], 'description': 'Chemotherapy medication', 'name': 'Gemcitabine', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Part B Cohort C'], 'description': 'Chemotherapy medication', 'name': 'Albumin-Bound Paclitaxel', '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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