Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT06819735
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, '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': '2025-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-02-06', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with DLTs, TEAEs, TRAEs, AESIs, SAEs and AEs leading to treatment discontinuation', 'timeFrame': 'Cycle 1 (21 days)', 'description': 'Proportion of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), adverse events of special interest (AESIs), serious adverse events (SAEs) and adverse events (AEs) leading to treatment discontinuation'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'From the first dose of study drug until the date of disease progression/recurrence, assessed up to 12 months', 'description': 'The anti-tumor activity will be determined based on the assessment of, but not limited to, the objective response rate (ORR). ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) at any time during the study according to RECIST v1.1 and immune RECIST (iRECIST) as assessed by the investigator.'}, {'measure': 'Serum concentrations of DT-7012', 'timeFrame': 'From the first dose of study drug until the date of end of treatment, assessed up to 12 months', 'description': 'Serum concentrations of DT-7012 will be determined to evaluate the pharmacokinetics (PK) of DT-7012'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is a phase 1/2, dose-escalation, clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of DT-7012 (an anti-CCR8 monoclonal antibody) as a single agent and in combination with an immune checkpoint inhibitor in adult participants with selected advanced solid tumors.', 'detailedDescription': 'This is a phase 1/2, first-in-human, multicenter, open-label clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of DT-7012, administered as monotherapy and in combination with an immune checkpoint inhibitor (ICI), in participants with selected recurrent advanced/metastatic solid tumors.\n\nThis study includes:\n\n* a phase 1 Monotherapy Dose Escalation\n* a phase 1b Combination Dose Escalation (this part will be initiated upon recommendation from the Safety Review Committee based on Monotherapy Dose Escalation data and corresponds to a dose escalation of a combination of DT-7012 with an ICI)\n* a subsequent phase 2 Indication-Specific Efficacy part\n\nThe phase 1 aims at determining the maximum tolerated dose or maximum administered dose of DT-7012 as single agent and in combination with an ICI, and the safety and tolerability of DT-7012 as single agent and in combination with an ICI in participants with selected recurrent advanced/metastatic solid tumors.\n\nThe phase 2 will assess the efficacy of DT-7012 as monotherapy and/or in combination with an ICI in indication-specific cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed solid tumor, among selected cancer types, that is recurrent, locally advanced (i.e., not eligible for curative surgery or radiotherapy) or metastatic, has progressed after at least one line of systemic therapy and has no established curative option.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the local site investigator/radiologist.\n* At least 1 tumour lesion accessible to biopsy per treating physician judgement.\n* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Any unresolved AEs from previous anti-cancer therapies of grade ≥2, with the exception of alopecia.\n* Prior severe immune-related AEs (irAEs) leading to immunotherapy treatment discontinuation.\n* Major surgery or significant traumatic injury within 4 weeks prior to Cycle 1 Day 1 with unadequately recovered AEs and/or complications from the intervention prior to Cycle 1 Day 1.\n* Prior radiotherapy within the 4 weeks prior to Cycle 1 Day 1 or limited field palliative radiotherapy within 2 weeks prior to Cycle 1 Day 1.\n* Prior anti-CCR8 monoclonal antibody treatment received in an investigational trial'}, 'identificationModule': {'nctId': 'NCT06819735', 'acronym': 'DOMISOL', 'briefTitle': 'Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Domain Therapeutics SA'}, 'officialTitle': 'A Phase 1/2, Multicentre, Open-label Clinical Trial of DT-7012 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Participants With Selected Advanced Solid Tumors (DOMISOL, DOmain_therapeutics Monoclonal antIbody for SOLid Tumors)', 'orgStudyIdInfo': {'id': 'DT-7012-CLI-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1A', 'description': 'Dose escalation of DT-7012 as a single agent', 'interventionNames': ['Drug: DT-7012']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1B', 'description': 'Dose escalation of DT-7012 in combination with an ICI', 'interventionNames': ['Drug: DT-7012', 'Drug: Immune checkpoint inhibitor']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2', 'description': 'Evaluation of DT-7012 as a sinle agent and/or in combination with an immune checkpoint inhibitor in indication-specific cohorts.', 'interventionNames': ['Drug: DT-7012', 'Drug: Immune checkpoint inhibitor']}], 'interventions': [{'name': 'DT-7012', 'type': 'DRUG', 'description': 'Intravenous infusion', 'armGroupLabels': ['Part 1A', 'Part 1B', 'Phase 2']}, {'name': 'Immune checkpoint inhibitor', 'type': 'DRUG', 'description': 'Intravenous infusion', 'armGroupLabels': ['Part 1B', 'Phase 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2109', 'city': 'North Ryde', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Macquarie University Clinical Trial Unit', 'geoPoint': {'lat': -33.79677, 'lon': 151.12436}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Cancer Research SA', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3199', 'city': 'Frankston', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Peninsula & South Eastern Haematology & Oncology Group', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'zip': '3144', 'city': 'Malvern', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Cabrini Health Limited', 'geoPoint': {'lat': -37.86259, 'lon': 145.02811}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'One Clinical Research Pty Ltd', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}], 'centralContacts': [{'name': 'Clinical Development', 'role': 'CONTACT', 'email': 'clinicaltrials@domaintherapeutics.com', 'phone': '0033390406150'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Domain Therapeutics Australia Pty Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Domain Therapeutics SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}