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

• Status: Not yet recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adanate, Inc

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