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

Launched by ADANATE, INC · Oct 28, 2022

Keywords

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Eligibility criteria

• 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