A Phase 1 Study of ADA-011 for Subjects With Advanced Solid Tumors

This study consists of dose escalation evaluation to determine the safety and tolerability of ADA-011 as a monotherapy and in combination with a checkpoint inhibitor. Following dose escalation, one or more dose expansion cohorts in selected indications will be explored to further evaluate the safety, tolerability, and preliminary efficacy of ADA-011.

Inclusion Criteria:Histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (nonresectable) or recurrent and progressing since the last antitumor therapy and for which no recognized standard therapy existsEastern Cooperative Oncology Group (ECOG) performance status ≤2Measurable disease per RECIST v1.1 or per other criteria best suited for the specific tumor type being evaluatedAdequate organ functionExclusion Criteria:Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 2 weeks prior to the first dose of ADA-011Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to the first dose of ADA-011Major trauma or major surgery within 4 weeks prior to the first dose of ADA-011AEs from prior anticancer therapy that have not resolved to Grade ≤1 except for alopeciaKnown, central nervous system (CNS) disease involvement, or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity.Evidence of active uncontrolled viral, bacterial, or systemic fungal infectionActive SARS-CoV-2 infection, irrespective of symptoms.History or risk of severe, chronic, untreated, or currently active autoimmune diseasePrior solid organ transplant or has had an allogenic hematopoietic stem cell transplant within the past 20 yearsPregnant, lactating, or breastfeeding