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

Prior treatment

• 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.
• Documented active Salmonella infection or vaccination with Salmonella typhi within 6 months prior to investigational product dosing

Other illness

• 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]
• Known history of cholelithiasis or urolithiasis
• History of valvular disease, arterial aneurisms or arterial or venous malformation

Other

• Known active brain metastases
• Additional protocol defined inclusion/exclusion criteria may apply

• 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
• 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 )
• Eastern Cooperative Oncology Group (ECOG) 0-1
• Adequate hematologic, hepatic, pulmonary, and cardiac function
• CD4 count >500/mL at screening
• Additional protocol defined inclusion criteria may apply