Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer
- Conditions
- NeoplasmsBreast NeoplasmsBreast CancerBreast Neoplasms, Triple-NegativeBreast Neoplasms, Hormone Receptor Positive/HER2 Negative
- Interventions
- Drug: CX-2009Drug: CX-072
- Registration Number
- NCT04596150
- Lead Sponsor
- CytomX Therapeutics
- Brief Summary
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
- Detailed Description
Eligible patients will be enrolled to the treatment arm based on breast cancer subtype.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARM C - CX-2009 Combination therapy, TNBC CX-072 CX-2009 and CX-072 Combination therapy in advanced, metastatic TNBC ARM A - CX-2009 Monotherapy, HR-positive/HER2-negative CX-2009 CX-2009 Monotherapy in advanced, metastatic Hormone Receptor (HR)-positive / Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer ARM B - CX-2009 Monotherapy, TNBC CX-2009 CX-2009 Monotherapy in advanced, metastatic Triple-Negative Breast Cancer (TNBC) ARM C - CX-2009 Combination therapy, TNBC CX-2009 CX-2009 and CX-072 Combination therapy in advanced, metastatic TNBC
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) 30 months ORR is the proportion of patients in the efficacy-evaluable population with a best response of Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Central Radiology Review (CRR)
- Secondary Outcome Measures
Name Time Method Clinical Benefit Rate (CBR) at 16 Weeks 30 Months This will include sum of confirmed Complete plus Partial Responses plus stable disease at 16 weeks on treatment
Duration of Response (DoR) 30 Months The time that measurement criteria are met for CR or PR (based on RECIST v1.1) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started)
Overall Survival (OS) 30 Months The time from treatment initiation until death as a result of any cause
Clinical Benefit Rate (CBR) at 24 Weeks 30 Months This will include sum of confirmed Complete plus Partial Responses plus stable disease at 24 weeks on treatment
Investigator-assessed Progression-Free Survival (PFS) 30 Months The time from the date of the first dose of study treatment until documentation of objective tumor progression based on RECIST v1.1 or until death due to any cause
Trial Locations
- Locations (42)
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, 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
FCS - South
🇺🇸Fort Myers, Florida, United States
MGH
🇺🇸Boston, Massachusetts, United States
DRCI
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Hematology Oncology Clinic
🇺🇸Baton Rouge, Louisiana, United States
Rocky Mountain Cancer Centers
🇺🇸Lone Tree, Colorado, United States
Moores Cancer Center
🇺🇸La Jolla, California, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
FCS - North
🇺🇸Saint Petersburg, Florida, United States
Hematology Oncology Assoc of the Treasure Coast
🇺🇸Port Saint Lucie, Florida, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
UPMC Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UT Health East Texas HOPE Cancer Center
🇺🇸Tyler, Texas, United States
Summit Cancer Centers
🇺🇸Spokane, Washington, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Soon Chun Hyang University Cheonan Hospital SCHMC
🇰🇷Cheonan, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Institut Catala Oncologia
🇪🇸Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Vall d'Hebron University Hospital
🇪🇸Barcelona, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Parc Tauli
🇪🇸Sabadell, Spain
Hospital Universitario Ramn y Cajal
🇪🇸Madrid, Spain
Hospital Universitario HM Sanchinarro
🇪🇸Madrid, Spain
NEXT Oncology
🇪🇸Madrid, Spain
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Indiana University Health Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
MUSC
🇺🇸Charleston, South Carolina, United States
Allina Health System
🇺🇸Minneapolis, Minnesota, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Huntsman Cancer Institute Research
🇺🇸Salt Lake City, Utah, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States