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

Eligibility 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
• 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