Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion

Description

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

Official Title

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)

Keywords

Solid Tumor, Adult Head and Neck Cancer Non Small Cell Lung Cancer Pancreatic Cancer Diffuse Large B Cell Lymphoma cancer solid tumor DLBCL CX-2029 PROBODY™ Therapeutic Drug Conjugate Antibody drug conjugate CD71 Transferrin receptor 1 Lymphoma Carcinoma, Non-Small-Cell Lung Pancreatic Neoplasms Lymphoma, B-Cell Head and Neck Neoplasms Lymphoma, Large B-Cell, Diffuse CX-2029 Escalation CX-2029 Biomarker CX-2029 Expansion

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
  2. 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
  3. Agreement to provide mandatory archival tissue or fresh biopsy
  4. At least 18 years of age

You CAN'T join if...

  1. Neuropathy > Grade 1
  2. Serious concurrent illness, including clinically relevant active infection
  3. Clinically significant iron metabolism disorders (eg, sickle cell anemia)
  4. Significant cardiac disease such as recent myocardial infarction
  5. 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;
  6. Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
  7. History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
  8. Currently receiving anticoagulation therapy with warfarin;
  9. Major surgery (requiring general anesthesia) within 3 months prior to dosing.
  10. . Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C)
  11. . Transfusion dependent anemia with transfusion dependency of ≥3 months
  12. . Use of iron chelators

Locations

  • University of Southern California accepting new patients
    Los Angeles California 90033 United States
  • Providence Portland Medical Center accepting new patients
    Portland Oregon 97213 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CytomX Therapeutics
ID
NCT03543813
Phase
Phase 1/2
Study Type
Interventional
Last Updated