A Phase 2, Open-Label, Multi-cohort Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors (PROCLAIM-CX-072)
Trial Description
To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in
adult patients with solid tumor based upon overall response rate by Response Evaluation
Criteria in Solid Tumors (RECIST)
Eligibility Requirements
Inclusion Criteria:
1. At least 18 years of age
2. Measurable disease as defined by RECIST v1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
4. Agree to provide tumor tissue and blood samples for biomarker assessment
Exclusion Criteria:
1. Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or
any investigational agent within 28 days prior to the first dose of study treatment.
2. Prior therapy with a chimeric antigen receptor T cell-containing regimen
3. History of active autoimmune disease(s) including but not limited to inflammatory
bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis,
systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune
neuropathies, type 1 insulin-dependent diabetes mellitus
4. History of myocarditis regardless of the cause
5. History of intolerance to prior checkpoint inhibitor therapy defined as the need to
discontinue treatment due to an irAE
6. History of any syndrome or medical condition that required treatment with systemic
steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications.
7. History of severe allergic or anaphylactic reactions to human mAb therapy or known
hypersensitivity to any Probody therapeutic