Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer
NCT ID: NCT04596150
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
PHASE2
125 participants
INTERVENTIONAL
2020-12-29
2023-06-02
Brief Summary
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Detailed Description
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Patients will receive study treatment on Day 1 of a Q3W cycle. Treatment with CX-2009 monotherapy (Arms A and B) or CX-2009 in combination with CX-072 (Arm C) will be given until disease progression or symptomatic deterioration, unacceptable toxicity necessitating treatment discontinuation, or if the patient meets certain study defined criteria for discontinuation. On-treatment tumor assessments, will occur every 6 weeks per RECIST v1.1 for the first 48 weeks, and every 12 weeks thereafter.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ARM A - CX-2009 Monotherapy, HR-positive/HER2-negative
CX-2009 Monotherapy in advanced, metastatic Hormone Receptor (HR)-positive / Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer
CX-2009
Intravenous administration of the CX-2009 of 6 mg/kg administered every 3 weeks (Q3W)
ARM B - CX-2009 Monotherapy, TNBC
CX-2009 Monotherapy in advanced, metastatic Triple-Negative Breast Cancer (TNBC)
CX-2009
Intravenous administration of the CX-2009 of 6 mg/kg administered every 3 weeks (Q3W)
ARM C - CX-2009 Combination therapy, TNBC
CX-2009 and CX-072 Combination therapy in advanced, metastatic TNBC
CX-2009
Intravenous administration of the CX-2009 of 6 mg/kg administered every 3 weeks (Q3W)
CX-072
Intravenous administration of the CX-072 of 1200 mg administered every 3 weeks (Q3W)
Interventions
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CX-2009
Intravenous administration of the CX-2009 of 6 mg/kg administered every 3 weeks (Q3W)
CX-072
Intravenous administration of the CX-072 of 1200 mg administered every 3 weeks (Q3W)
Eligibility Criteria
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Inclusion Criteria
* Arm B and Arm C: inoperable, locally advanced or metastatic TNBC; archival or fresh tumor tissue must have high CD166 expression by immunohistochemistry (IHC). Patients must have received 1 - 3 prior lines of therapy for inoperable, locally advanced, or metastatic TNBC
* Arm C only: Patients must be Programmed Death Ligand 1 (PD-L1) positive by an FDA-approved test. For patients who have received prior checkpoint inhibitors (CPI) therapy: if the CPI was the most recent treatment given prior to enrollment into this study, the patient must not have progressed within 120 days of the first dose of the CPI
* Measurable disease per RECIST v1.1
* Adults, at least 18 years of age
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Adequate baseline Laboratory Values
* Patients of childbearing potential or those with partners of childbearing potential must agree to use a highly effective method of birth control at least 1 month prior to first dose, during study treatment, and for a period of 50 days after the last dose of CX-2009 and 105 days after the last dose of CX-072 (Arm C).
* Patients with brain metastases that are ≤ 1 cm, are asymptomatic, and require no treatment may be eligible after discussion with Medical Monitor.
Exclusion Criteria
* Untreated symptomatic brain and/or leptomeningeal metastases
* Unresolved prior therapy-related acute toxicity Grade \> 1, including neuropathy. Alopecia and other nonacute toxicities are not exclusionary
* Active or chronic corneal disorder
* Serious concurrent illness
* History of allogeneic tissue/solid organ transplant, stem cell transplant, or bone marrow transplant
* Arm C only:
* History of or current active autoimmune diseases
* History of myocarditis regardless of the cause
* History of intolerance to prior immune CPI therapy defined as the need to discontinue treatment due to an immune-related Adverse Event (AE)
* Immunosuppressive therapy including chronic systemic steroid (≥ 10 mg daily prednisone equivalents) within 14 days of Cycle 1 Day 1 (C1D1). However, patients who require brief courses of steroids (eg, as prophylaxis for IV contrast or for treatment of an allergic reaction) may be eligible with Medical Monitor approval. Inhaled or topical steroids are permitted.
* History of severe allergic or anaphylactic reactions to previous monoclonal antibody (mAb) therapy or known hypersensitivity to any component of Probody therapeutic
* Prior treatment with maytansinoid-containing drug conjugates (eg, DM1 or DM4 antibody drug conjugate, including trastuzumab emtansine)
* Pregnant or breastfeeding
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
Locations
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Moores Cancer Center
La Jolla, California, United States
Los Angeles Hematology Oncology Medical
Los Angeles, California, United States
USC Norris Cancer Center
Los Angeles, California, United States
UCLA David Geffen
Santa Monica, California, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States
FCS - South
Fort Myers, Florida, United States
Baptist Medical Center
Jacksonville, Florida, United States
Hematology Oncology Assoc of the Treasure Coast
Port Saint Lucie, Florida, United States
FCS - North
St. Petersburg, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
MGH
Boston, Massachusetts, United States
DRCI
Boston, Massachusetts, United States
Allina Health System
Minneapolis, Minnesota, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Montefiore Medical Center
The Bronx, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
MUSC
Charleston, South Carolina, United States
Tennessee Oncology
Nashville, Tennessee, United States
UT Health East Texas HOPE Cancer Center
Tyler, Texas, United States
Huntsman Cancer Institute Research
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Summit Cancer Centers
Spokane, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Soon Chun Hyang University Cheonan Hospital SCHMC
Cheonan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Vall d'Hebron University Hospital
Barcelona, , Spain
Institut Catala Oncologia
Barcelona, , Spain
Hospital Universitario Ramn y Cajal
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
NEXT Oncology
Madrid, , Spain
Hospital Parc Tauli
Sabadell, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Countries
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Other Identifiers
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2020-004618-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTMX-2009-002
Identifier Type: -
Identifier Source: org_study_id
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