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

NCT ID: NCT06336148

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-05
• Study Completion Date: 2025-08-28

Brief 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.

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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

ACTM-838

Intervention Type: DRUG

Escalating doses of ACTM-838 in Part 1a and recommended dose in Part 1b

Interventions

ACTM-838

Escalating doses of ACTM-838 in Part 1a and recommended dose in Part 1b

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actym Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Southern California Norris Comprehensive Cancer Center, 1441 Eastlake Ave.

Los Angeles, California, United States

UPMC Hillman Cancer Center, 5115 Centre Ave

Pittsburgh, Pennsylvania, United States

Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200

Westmead, New South Wales, Australia

Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202

Bedford Park, South Australia, Australia

Alfred Hospital, 55 Commercial Road, Site No: 201

Melbourne, Victoria, Australia

Countries

United States; Australia

Other Identifiers

ACTM-838-01

Identifier Type: -

Identifier Source: org_study_id