nctId: NCT06336148 id: ACTM-838-01 briefTitle: A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-07 date: 2024-03-28 date: 2024-03-28 name: Actym Therapeutics, Inc. class: INDUSTRY 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. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an Open label Single dose study. primaryPurpose: TREATMENT masking: NONE maskingDescription: Open label count: 35 type: ESTIMATED name: ACTM-838 measure: Incidence and severity of adverse events and serious adverse events - Part 1a and Part 1b measure: Proportion of participants experiencing dose limiting toxicities - Part 1a and 1b measure: Objective response rate (ORR) as defined as complete response (CR) or partial response (PR) - Part 1a and Part 1b measure: Confirmed ORR defined as confirmed CR or confirmed PR - Part 1b measure: Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1b measure: Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1b measure: Progression free survival (PFS) - Part 1b measure: Change in tumor markers - Part 1b measure: Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1b measure: Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a measure: Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a measure: Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a measure: Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a measure: Progression free survival (PFS) - Part 1a measure: Change in tumor markers - Part 1a measure: Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a measure: Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200 city: Westmead state: New South Wales zip: 2145 country: Australia name: Mark Wong, Dr role: CONTACT phone: +61 2 9845 5200 email: mark.wong@sydney.edu.au lat: -33.80383 lon: 150.98768 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 name: Ganessan Kichenadasse, Dr role: CONTACT phone: +61 491 670 039 email: clinicaltrials@socru.org.au lat: -35.03333 lon: 138.56667 facility: Alfred Hospital, 55 Commercial Road, Site No: 201 city: Melbourne state: Victoria zip: 3004 country: Australia name: Andrew Haydon, Dr role: CONTACT phone: +61 3 9076 3129 email: andrew.haydon@monash.edu.au lat: -37.814 lon: 144.96332 hasResults: False