Study of 23ME-01473 in Patients With Advanced Solid Malignancies
This is a first-in-human open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-01473 given by intravenous infusion in participants with advanced solid cancers who have progressed or are intolerant of available standard therapies.
- EligibilityCriteria: Inclusion Criteria:  Phase 1: Adults ≥ 18 years of age Phase 1: Histologically-diagnosed locally advanced (unresectable), or metastatic carcinoma or sarcoma that has progressed after standard therapy for the specific tumor type. Adults 18+: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Life expectancy ≥ 12 weeks Phase 1: Participants with evaluable disease are eligible regardless of tumor type, RECIST 1.1 can be used to assess disease progression.  Exclusion Criteria:  Females who are pregnant (positive serum pregnancy test within 7 days prior to study drug administration) or breastfeeding.  Immune-Related Medical History  Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years Receipt of systemic immunosuppressive therapy (e.g. steroids) within 4 weeks prior to the start of study drug administration History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia, non-infectious pneumonia that required steroids, or evidence of active, non-infectious pneumonitis History of Grade ≥ 3 immune-mediated toxicity Prior allogeneic or autologous bone marrow transplant, or other solid organ transplant  History of a positive test for:  Hepatitis C virus (HCV) infection, except for those who have completed curative therapy for HCV and have undetectable HCV RNA Hepatitis B virus (HBV) infection, except for those who are receiving treatment with HBV-active nucleos(t)ide antiviral therapy at the time of study entry and have undetectable HBV DNA Human Immunodeficiency Virus (HIV) infection, except those who meet the following criteria: CD4+ T cells ≥ 350 cells/μL, no history of Acquired Immunodeficiency Syndrome (AIDS)-defining opportunistic infections, HIV RNA < 50 copies/mL, and on a stable antiretroviral regimen for at least 3 months Prior anticancer therapy, including chemotherapy, targeted therapy, biological therapy or immune-checkpoint inhibitors within 4 weeks or 5 drug half-lives (whichever is shorter) History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free. Uncontrolled or symptomatic CNS (central nervous system) metastases and/or carcinomatous meningitis Recent history (within 6 months) of serious cardiovascular disease - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 110 Years - StdAgeList: Adult, Older Adult