A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors - Trial NCT06336148
Access comprehensive clinical trial information for NCT06336148 through Pure Global AI's free database. This Phase 1 trial is sponsored by Actym Therapeutics, Inc. and is currently Not yet recruiting. The study focuses on Solid Tumor. Target enrollment is 35 participants.
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Study Focus
Sponsor & Location
Actym Therapeutics, Inc.
Timeline & Enrollment
Phase 1
Apr 01, 2024
Jul 01, 2026
Primary Outcome
Incidence and severity of adverse events and serious adverse events - Part 1a and Part 1b,Proportion of participants experiencing dose limiting toxicities - Part 1a and 1b,Objective response rate (ORR) as defined as complete response (CR) or partial response (PR) - Part 1a and Part 1b,Confirmed ORR defined as confirmed CR or confirmed PR - Part 1b,Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1b,Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1b,Progression free survival (PFS) - Part 1b,Change in tumor markers - Part 1b,Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1b
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06336148
Non-Device Trial