PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Lymphoma, Pancreatic Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/26/2018 |
Start Date: | June 15, 2018 |
End Date: | December 2022 |
Contact: | Annie Weaver, PhD |
Email: | clinicaltrials@cytomx.com |
Phone: | 650-515-3185 |
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)
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
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
Inclusion Criteria:
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
Exclusion Criteria:
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
We found this trial at
5
sites
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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