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A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

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Record identity and dates

Source
ClinicalTrials.gov
Source record ID
NCT05086692
Title field or adapter rule
{'original_value': 'A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At
2026-10-31T23:27:19.562392+00:00
Published At
2026-10-30T00:00:00+00:00
Record Updated At
2026-10-30
Source Retrieved At
2026-10-31T22:19:02.163121+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

Fields recorded by this source

protocolSection.conditionsModule.conditions
["Advanced Solid Tumor", "Unresectable Solid Tumor", "Clear Cell Renal Cell Carcinoma", "Triple Negative Breast Cancer", "Non-Small Cell Lung Cancer Squamous", "Non-Small Cell Lung Cancer Non-squamous", "Colorectal Cancer (MSI-H)", "Gastric Cancer", "Cervical Cancer", "Basal Cell Carcinoma", "Bladder Cancer", "Merkel Cell Carcinoma", "Squamous Cell Carcinoma of Head and Neck", "Cutaneous Squamous Cell Carcinoma", "Pleural Mesothelioma", "Esophageal Cancer", "Endometrial Carcinoma", "Solid Tumor", "Solid Tumor, Adult", "MSI-H Solid Malignant Tumor", "Cancer With A High Tumor Mutational Burden", "Epithelial Ovarian Carcinoma", "Primary Peritoneal Cancer", "Gastroesophageal Junction (GEJ) Cancer", "Acral Melanoma", "Mucosal Melanoma", "Cutaneous Melanoma", "DMMR Solid Malignant Tumor", "Fallopian Tube Cancer", "Ovarian Cancer", "MSI-H Cancer", "DMMR Cancer", "Pancreas Adenocarcinoma (MSI-H)", "Skin Cancer", "Viral Cancer", "Cervical Cancers", "Endometrial Cancer"]
protocolSection.statusModule.lastUpdatePostDateStruct
{"date": "2026-10-30", "type": "ACTUAL"}
protocolSection.identificationModule.nctId
"NCT05086692"
protocolSection.identificationModule.officialTitle
"A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors"
protocolSection.statusModule.overallStatus
"ACTIVE_NOT_RECRUITING"
protocolSection.designModule.phases
["PHASE1", "PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct
null

Study condition terms

  • Advanced Solid Tumor (protocolSection.conditionsModule.conditions)
  • Unresectable Solid Tumor (protocolSection.conditionsModule.conditions)
  • Clear Cell Renal Cell Carcinoma (protocolSection.conditionsModule.conditions)
  • Triple Negative Breast Cancer (protocolSection.conditionsModule.conditions)
  • Non-Small Cell Lung Cancer Squamous (protocolSection.conditionsModule.conditions)
  • Non-Small Cell Lung Cancer Non-squamous (protocolSection.conditionsModule.conditions)
  • Colorectal Cancer (MSI-H) (protocolSection.conditionsModule.conditions)
  • Gastric Cancer (protocolSection.conditionsModule.conditions)
  • Cervical Cancer (protocolSection.conditionsModule.conditions)
  • Basal Cell Carcinoma (protocolSection.conditionsModule.conditions)
  • Bladder Cancer (protocolSection.conditionsModule.conditions)
  • Merkel Cell Carcinoma (protocolSection.conditionsModule.conditions)
  • Squamous Cell Carcinoma of Head and Neck (protocolSection.conditionsModule.conditions)
  • Cutaneous Squamous Cell Carcinoma (protocolSection.conditionsModule.conditions)
  • Pleural Mesothelioma (protocolSection.conditionsModule.conditions)
  • Esophageal Cancer (protocolSection.conditionsModule.conditions)
  • Endometrial Carcinoma (protocolSection.conditionsModule.conditions)
  • Solid Tumor (protocolSection.conditionsModule.conditions)
  • Solid Tumor, Adult (protocolSection.conditionsModule.conditions)
  • MSI-H Solid Malignant Tumor (protocolSection.conditionsModule.conditions)
  • Cancer With A High Tumor Mutational Burden (protocolSection.conditionsModule.conditions)
  • Epithelial Ovarian Carcinoma (protocolSection.conditionsModule.conditions)
  • Primary Peritoneal Cancer (protocolSection.conditionsModule.conditions)
  • Gastroesophageal Junction (GEJ) Cancer (protocolSection.conditionsModule.conditions)
  • Acral Melanoma (protocolSection.conditionsModule.conditions)
  • Mucosal Melanoma (protocolSection.conditionsModule.conditions)
  • Cutaneous Melanoma (protocolSection.conditionsModule.conditions)
  • DMMR Solid Malignant Tumor (protocolSection.conditionsModule.conditions)
  • Fallopian Tube Cancer (protocolSection.conditionsModule.conditions)
  • Ovarian Cancer (protocolSection.conditionsModule.conditions)
  • MSI-H Cancer (protocolSection.conditionsModule.conditions)
  • DMMR Cancer (protocolSection.conditionsModule.conditions)
  • Pancreas Adenocarcinoma (MSI-H) (protocolSection.conditionsModule.conditions)
  • Skin Cancer (protocolSection.conditionsModule.conditions)
  • Viral Cancer (protocolSection.conditionsModule.conditions)
  • Cervical Cancers (protocolSection.conditionsModule.conditions)
  • Endometrial Cancer (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

  • {'armGroupLabels': ['MDNA11'], 'description': 'Dose escalation/evaluation - MDNA11 will be administered, IV on a once every 2 weeks (Q2W) dosing schedule. Provisional dose cohorts for monotherapy dose escalation doses ranging from 0.003 to 0.6 (mg/kg) until determining the monotherapy Recommended Dose for Expansion (mRDE).\n\nDose expansion - MDNA11 will be administered according to defined mRDE', 'name': 'MDNA11', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['MDNA11'], 'description': 'Dose escalation/evaluation - MDNA11 will be administered in combination with pembrolizumab, IV. MDNA11 dose range to be evaluated in combination with pembrolizumab until determining the combination Recommended Dose for Expansion (cRDE).\n\nDose expansion - MDNA11+ pembrolizumab will be administered according to defined cRDE', 'name': 'Pembrolizumab (KEYTRUDA®)', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

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

Drug names recorded in this source

  • MDNA11 (protocolSection.armsInterventionsModule.interventions[].name)
  • Pembrolizumab (KEYTRUDA®) (protocolSection.armsInterventionsModule.interventions[].name)

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

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