A Phase 1a/1b Study of ACTM-838 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.
Checked against the public recordLast updated Oct 15, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Actym Therapeutics, Inc.
- Interventions being studied
- Drug: ACTM-838
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Southern California Norris Comprehensive Cancer Center, 1441 Eastlake Ave.Los Angeles, California
- UPMC Hillman Cancer Center, 5115 Centre AvePittsburgh, Pennsylvania
- Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200Westmead, New South Wales
- Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202Bedford Park, South Australia
- Alfred Hospital, 55 Commercial Road, Site No: 201Melbourne, Victoria
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 15, 2025. Always confirm current availability with the study team.