protocolSection identificationModule nctId: NCT06336148, orgStudyIdInfo id: ACTM-838-01, briefTitle: A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Actym Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a first in human (FIH) 2-part study using ACTM-838 in patients with advanced solid tumors resistant to standard of care treatment. Part 1a will evaluate dose escalation and Part 1b will evaluate dose expansion., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is an Open label Single dose study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open label, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: ACTM-838, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events and serious adverse events - Part 1a and Part 1b, primaryOutcomes measure: Proportion of participants experiencing dose limiting toxicities - Part 1a and 1b, primaryOutcomes measure: Objective response rate (ORR) as defined as complete response (CR) or partial response (PR) - Part 1a and Part 1b, primaryOutcomes measure: Confirmed ORR defined as confirmed CR or confirmed PR - Part 1b, primaryOutcomes measure: Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1b, primaryOutcomes measure: Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1b, primaryOutcomes measure: Progression free survival (PFS) - Part 1b, primaryOutcomes measure: Change in tumor markers - Part 1b, primaryOutcomes measure: Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1b, secondaryOutcomes measure: Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a, secondaryOutcomes measure: Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a, secondaryOutcomes measure: Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a, secondaryOutcomes measure: Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a, secondaryOutcomes measure: Progression free survival (PFS) - Part 1a, secondaryOutcomes measure: Change in tumor markers - Part 1a, secondaryOutcomes measure: Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a, secondaryOutcomes measure: Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200, city: Westmead, state: New South Wales, zip: 2145, country: Australia, contacts name: Mark Wong, Dr, role: CONTACT, phone: +61 2 9845 5200, email: mark.wong@sydney.edu.au, geoPoint lat: -33.80383, lon: 150.98768, locations facility: Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202, city: Bedford Park, state: South Australia, zip: 5042, country: Australia, contacts name: Ganessan Kichenadasse, Dr, role: CONTACT, phone: +61 491 670 039, email: clinicaltrials@socru.org.au, geoPoint lat: -35.03333, lon: 138.56667, locations facility: Alfred Hospital, 55 Commercial Road, Site No: 201, city: Melbourne, state: Victoria, zip: 3004, country: Australia, contacts name: Andrew Haydon, Dr, role: CONTACT, phone: +61 3 9076 3129, email: andrew.haydon@monash.edu.au, geoPoint lat: -37.814, lon: 144.96332, hasResults: False