Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-29 @ 6:48 AM
Study NCT ID:
NCT06293651
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2024-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-02-27', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria', 'timeFrame': 'Cycle 1(21 days) in dose escalation', 'description': 'The recommended Phase 2 dose(RP2D) will be the optimal biological dose (OBD) based on consideration of safety and tolerability information along with all available pharmacokinetic (PK), pharmacodynamic (PD), and efficacy data.'}, {'measure': 'PK parameters for DA-4505 (Peak Plasma Concentration (Cmax))', 'timeFrame': 'Day 1 and 2 of first 2 cycles (every 21 days)', 'description': 'Determine DA-4505 Cmax'}, {'measure': 'PK parameters for DA-4505 (Area Under the Curve (AUC))', 'timeFrame': 'Day 1 and 2 of first 2 cycles (every 21 days)', 'description': 'Determine DA-4505 AUC'}, {'measure': 'PK parameters for DA-4505 (half-life (t1/2))', 'timeFrame': 'Day 1 and 2 of first 2 cycles (every 21 days)', 'description': 'Determine DA-4505 half-life (t1/2).'}, {'measure': 'Response per revised "Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1)', 'timeFrame': 'approximately 12 months', 'description': 'To determine the anti-tumor activity of both DA-4505 as a single agent and in combination with pembrolizumab'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced or Metastatic Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This study is an Open-Label, Phase 1/2a, First-in-Human, Dose-Escalation, Dose-Expansion, and Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 and older.\n2. Capable of giving signed informed consent.\n3. Diagnosed with particular disease characteristics.\n4. Expected survival ≥ 3 months.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.\n6. A female patient is eligible to participate if she is not pregnant or breastfeeding.\n7. A male patient is eligible to participate if he agrees to remain abstinent or use a male condom when having sexual intercourse with a WOCBP, or if he has had a bilateral vasectomy.\n8. Have measurable disease by revised RECIST v1.1 criteria.\n\nExclusion Criteria:\n\n1. Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption.\n2. Current enrollment or past participation in another clinical trial.\n3. Unresolved adverse reactions (except alopecia) from previous cancer-directed therapy.\n4. Use of cancer-directed therapies, including chimeric antigen receptor T cell therapy.\n5. Autologous transplantation within 60 days.\n6. Prior allogeneic transplantation.\n7. Major surgery within 30 days, or unresolved complications after a major or minor surgery.\n8. History of or currently active cardiovascular disease.\n9. Clinically significant respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.\n10. History of other malignancy.'}, 'identificationModule': {'nctId': 'NCT06293651', 'briefTitle': 'Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'an Open-Label, Phase 1/2a, First-in-Human Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'DA4505_AMST_I/IIa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monotherapy', 'description': 'Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Pharmacodynamic Biomarkers', 'interventionNames': ['Drug: DA-4505']}, {'type': 'EXPERIMENTAL', 'label': 'Combination with Pembrolizumab', 'description': 'Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Proof of concept Phase 2a: Pharmacodynamic Biomarkers', 'interventionNames': ['Drug: DA-4505 + Pembrolizumab']}], 'interventions': [{'name': 'DA-4505', 'type': 'DRUG', 'description': 'Phase 1a: Dose escalation Phase 1b: OBD and MTD Phase 2a: RP2D', 'armGroupLabels': ['Monotherapy']}, {'name': 'DA-4505 + Pembrolizumab', 'type': 'DRUG', 'description': 'Phase 1a/b: OBD, MTD of DA-4505 + 200mg of Pembrolizumab Phase 2a: RP2D of DA-4505 + 200mg of Pembrolizumab', 'armGroupLabels': ['Combination with Pembrolizumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jayun Jang', 'role': 'CONTACT', 'email': 'janycan@donga.co.kr', 'phone': '+82-2-920-8306'}, {'name': 'Hye-yeong Han', 'role': 'CONTACT', 'email': 'hyhan@donga.co.kr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}