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

A Phase 1, Open-Label, Multicenter Study of ADA-011 as Monotherapy and in Combination With a Checkpoint Inhibitor 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. 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 exists
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Measurable disease per RECIST v1.1 or per other criteria best suited for the specific tumor type being evaluated
• Adequate organ function

Exclusion 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-011
• Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to the first dose of ADA-011
• Major trauma or major surgery within 4 weeks prior to the first dose of ADA-011
• AEs from prior anticancer therapy that have not resolved to Grade ≤1 except for alopecia
• Known, 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 infection
• Active SARS-CoV-2 infection, irrespective of symptoms.
• History or risk of severe, chronic, untreated, or currently active autoimmune disease
• Prior solid organ transplant or has had an allogenic hematopoietic stem cell transplant within the past 20 years
• Pregnant, lactating, or breastfeeding