PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL
NCT ID: NCT03543813
Last Updated: 2024-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
133 participants
INTERVENTIONAL
2018-06-15
2023-06-01
Brief Summary
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PROCLAIM: PRObody CLinical Assessment In Man CX-2029 clinical trial 001
PROBODY is a trademark of CytomX Therapeutics, Inc
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Detailed Description
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The study is divided into 3 parts (arms), as follows:
* Part A: Dose escalation and determination of the Maximum tolerated dose (MTD) and/or Recommended Phase 2 dose (RP2D)
* Part B: Characterization of CX-2029 in the Tumor microenvironment (TME) in subjects with select tumor types using previously cleared dose levels from Part A
* Part C: Expansions in select tumor types at the MTD/RP2D as established in Part A
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CX-2029 Escalation
Dose Escalation and Determination
CX-2029
CX-2029 Monotherapy
CX-2029 Biomarker
Characterization of CX-2029 in the tumor microenvironment in subjects with select tumor types
CX-2029
CX-2029 Monotherapy
CX-2029 Expansion
Evaluate antitumor activity of CX-2029
CX-2029
CX-2029 Monotherapy
Interventions
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CX-2029
CX-2029 Monotherapy
Eligibility Criteria
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Inclusion Criteria
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
5. For Arm A, histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor
6. 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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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CytomX Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Monika Vainorius, M.D.
Role: STUDY_DIRECTOR
CytomX Therapeutics, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
California Cancer Associates for Research and Excellence
Encinitas, California, United States
University of Southern California
Los Angeles, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Florida Cancer Specialists
Lake Mary, Florida, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
START Midwest
Grand Rapids, Michigan, United States
Forrest General Cancer Center
Hattiesburg, Mississippi, United States
Washington University - St. Louis
St Louis, Missouri, United States
New York University (NYU) Clinical Cancer Center
New York, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Kangbuk Samsung Hospital
Seoul, Jongno-gu, South Korea
Severance Hospital- Yonsei Cancer Center
Seoul, Seodaemun-gu, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario La Paz, Servicio de Oncología
Madrid, , Spain
Centro Integral Oncologico Clara Campal, START Madrid
Madrid, , Spain
Hospital Universitario Quiron de Madrid
Madrid, , Spain
The Christie NHS Foundation Trust
Withington, Manchester Greater, United Kingdom
Beatson, West of Scotland Cancer Centre
Glasgow, , United Kingdom
Countries
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Other Identifiers
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CTMX-M-2029-001
Identifier Type: -
Identifier Source: org_study_id
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