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

October 14, 2025 updated by: Actym Therapeutics, Inc.

A Phase 1a/1b Open-label, Dose-Escalation and Expansion Study of ACTM-838 as a Single Agent in Patients With Advanced Solid Tumors

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study has 2 parts. Part 1a will evaluate the safety and tolerability and activity of escalating doses of ACTM-838 to estimate the maximum tolerated dose (MTD) and/or the optimum biological dose (OBD) for ACTM-838 as a monotherapy and determine the dose recommended for Part 1b.

Part 1b will further evaluate ACTM-838 in patients with advanced specific tumor types (defined pathologically, clinically and/or molecularly) based on data emerging from the Phase 1a and the pre-clinical program. The details on the Phase 1b dose expansion part will be incorporated in a future protocol amendment.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital, 55 Commercial Road, Site No: 201
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California Norris Comprehensive Cancer Center, 1441 Eastlake Ave.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Center, 5115 Centre Ave

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Advanced solid tumor for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit, or they must be ineligible to receive or refuse to receive such therapy
  2. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST ) v1.1; amenable for biopsy, and radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI )
  3. Eastern Cooperative Oncology Group (ECOG) 0-1
  4. Adequate hematologic, hepatic, pulmonary, and cardiac function
  5. CD4 count >500/mL at screening
  6. Additional protocol defined inclusion criteria may apply

Exclusion Criteria:

  1. Active autoimmune disease requiring systemic treatment (i.e., with use of disease modifying agents, systemic corticosteroids or immunosuppressive drug) within the past 6 months prior to dosing of investigational product.
  2. History of permanent artificial implants (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopaedic screw[s], metal plate[s], bone graft[s], or other exogenous implant[s]
  3. Known history of cholelithiasis or urolithiasis
  4. History of valvular disease, arterial aneurisms or arterial or venous malformation
  5. Known active brain metastases
  6. Documented active Salmonella infection or vaccination with Salmonella typhi within 6 months prior to investigational product dosing
  7. Additional protocol defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACTM-838 Monotherapy
Escalating doses of ACTM-838 in Part 1a followed by expansion in Part 1b at the recommended dose determined in Part 1a
Drug: ACTM-838
Escalating doses of ACTM-838 in Part 1a and recommended dose in Part 1b

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events and serious adverse events - Part 1a
Time Frame: 1 year
1 year
Proportion of participants experiencing dose limiting toxicities - Part 1a
Time Frame: 28 Days
28 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a
Time Frame: 1 year
1 year
Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a
Time Frame: 1 year
1 year
Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a
Time Frame: 1 year
1 year
Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a
Time Frame: 1 year
1 year
Progression free survival (PFS) - Part 1a
Time Frame: 1 year
1 year
Change in tumor markers - Part 1a
Time Frame: 1 year
1 year
Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a
Time Frame: 1 year
1 year
Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a
Time Frame: 1 year
1 year
Incidence of antidrug antibodies (ADA) to ACTM-838 - Part 1a
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actym Therapeutics, Inc.

Investigators

  • Study Director: SVP, Clinical Development, MD, PhD, Actym Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2024

Primary Completion (Actual)

August 28, 2025

Study Completion (Actual)

August 28, 2025

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Estimated)

October 15, 2025

Last Update Submitted That Met QC Criteria

October 14, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTM-838-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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