A Phase 1-2, First-in-Human Study of CX-2029 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors or Diffuse Large B-cell Lymphomas (PROCLAIM-CX-2029)
Description
Brief Summary
The purpose of this first-in-human study of CX-2029 is to characterize the safety,
tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2029
in adult subjects with metastatic or locally advanced unresectable solid tumors or diffuse
large B-cell lymphoma (DLBCL). PROCLAIM: PRObody CLinical Assessment In Man CX-2029 clinical
trial 001
PROBODY is a trademark of CytomX Therapeutics, Inc
Phase
N/AInclusion and Exclusion 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
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.