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NCT06336148

A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors

A Phase 1a/1b Open-label, Dose-Escalation and Expansion Study of ACTM-838 as a Single Agent in Patients With Advanced Solid Tumors
Actym Therapeutics, Inc.·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Solid Tumor
Drug/Device/Intervention
ACTM-838
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Actym Therapeutics, Inc.
Location
Westmead,Bedford Park,Melbourne, Australia
Timeline & enrollment
Phase
Phase 1
Start date
Apr 01, 2024
End date
Jul 01, 2026
Enrollment
35 participants
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
Malignant neoplasm: Connective and soft tissue, unspecifiedCarcinoma in situ, unspecifiedMalignant neoplasm: ParametriumMalignant neoplasm of other connective and soft tissueMalignant neoplasm: Lip, unspecified, inner aspect
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06336148
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.