PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
• Patients demonstrating disease progression after treatment with approved therapies that are known to confer life-prolonging benefit, or who are intolerant to or have declined treatment
• Agreement to provide mandatory archival tissue or fresh biopsy
• At least 18 years of age
• For Arm A, histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor
• For Arms B and C, histologically or cytologically confirmed metastatic or locally advanced unresectable HNSCC, DLBCL, NSCLC (squamous cell histology only), or esophageal (EAC, ESCC, or GE junction) cancer
• Additional inclusion criteria may apply

Exclusion Criteria

• Neuropathy > Grade 1
• Serious concurrent illness, including clinically relevant active infection
• Clinically significant iron metabolism disorders (eg, sickle cell anemia)
• Significant cardiac disease such as recent myocardial infarction
• History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
• Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
• History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
• Currently receiving anticoagulation therapy with warfarin;
• Major surgery (requiring general anesthesia) within 3 months prior to dosing.
• Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C)
• Transfusion dependent anemia with transfusion dependency of ≥3 months
• Use of iron chelators
• Additional exclusion criteria may apply