Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer

Completed · Phase 2

Conditions studied: Neoplasms, Breast Neoplasms, Breast Neoplasms, Triple-Negative, Breast Cancer, Breast Neoplasms, Hormone Receptor Positive/HER2 Negative

In brief

A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC

Key facts

Study ID

NCT04596150

Run by

CytomX Therapeutics

People needed

125

Starts

2020-12-29

Expected to finish

2023-06-02

Last updated by the study team

2024-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Arm A: inoperable, locally advanced or metastatic HR-positive/HER2-negative breast cancer. Patients must have received 0 to 2 prior cytotoxic chemotherapy in the inoperable, locally advanced, or metastatic setting
• 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.
• Additional inclusion criteria may apply

You may not qualify if…

• History of malignancy that was active within the previous 2 years. Exceptions include localized cancers that are not related to the current cancer being treated, that are considered to have been cured, and in the opinion of the Investigator present a low risk for recurrence
• 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
• Additional exclusion criteria may apply

Where it is running

• 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

Full record on ClinicalTrials.gov

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