Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 12:14 AM
Study NCT ID:
NCT07312903
Status:
RECRUITING
Last Update Posted:
2026-01-12
First Post:
2025-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DPTX3186 in Wnt Pathway Activated Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-08', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2025-12-17', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment emergent adverse events and serious adverse events.', 'timeFrame': 'Up to 36 Months', 'description': '1. Outcome Measure: Incidence of Treatment Emergent Adverse-Events Measure Description: Number of subjects with treatment-emergent adverse events (TEAEs) Time Frame: up to 36 months\n2. Outcome Measure: Incidence of Serious Adverse Events Measure Description: Number of subjects with serious adverse events (SAEs) Time Frame: up to 36 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is a first-in human clinical study of DPTX3186 in subjects with Wnt-pathway activated solid tumors where no other treatments exist. The study will evaluate safety, pharmacokinetics, and initial activity of DPTX3186, as well as explore pharmacodynamic parameters to identify potential biomarkers of efficacy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed solid tumor and tumor types known to be Wnt-pathway activated (such as colorectal cancer, gastric cancer, lung cancer, and triple negative breast cancer) and no other approved treatment options available.\n* At least one measurable target lesion as defined by RECIST v1.1 on CT, PET/CT, or MRI.\n* ECOG performance status of 0 or 1.\n* Physiological conditions that may prevent absorption of an oral medication including but not limited to colostomy and ileostomy.\n* Age ≥18 years (or ≥ age of majority per local regulation)\n* Life expectancy ≥3 months\n* Willing and able to comply with protocol requirements\n\nExclusion Criteria:\n\n* Symptomatic or uncontrolled brain metastasis requiring concurrent treatment,\n* Another known malignancy that is progressing or requires active treatment within the last 2 years (except basal cell carcinoma, in situ cervical cancer, etc.).\n* Inadequate organ function\n* Known hypersensitivity to study drug or excipients'}, 'identificationModule': {'nctId': 'NCT07312903', 'briefTitle': 'DPTX3186 in Wnt Pathway Activated Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dewpoint Therapeutics'}, 'officialTitle': 'An Open Label, Multicenter Study of DPTX3186 to Evaluate Safety, Tolerability, and Pharmacokinetics in Subjects With Known Wnt Pathway Activated Solid Tumors Where No Other Treatments Exist', 'orgStudyIdInfo': {'id': 'DPTX3186-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation', 'interventionNames': ['Drug: DPTX3186']}], 'interventions': [{'name': 'DPTX3186', 'type': 'DRUG', 'description': 'Once daily (single dose of study drug in the morning in fasted conditions) for 4 consecutive days (4 days on) and 3 days off in a cycle of 28 days', 'armGroupLabels': ['Dose Escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jordan Georg', 'role': 'CONTACT', 'email': 'jgeorg@nextoncology.com', 'phone': '210-580-9521'}], 'facility': 'NEXT San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maybelle de la Rosa', 'role': 'CONTACT', 'email': 'mdelarosa@nextoncology.com', 'phone': '703-783-4518'}], 'facility': 'NEXT Virginia', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dewpoint Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}