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.
Powered by
SC CTSI