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
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Objective Response Rate (ORR)
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)
Time frame: 30 months
Investigator-assessed Progression-Free Survival (PFS)
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
Time frame: 30 Months
Duration of Response (DoR)
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)
Time frame: 30 Months
Overall Survival (OS)
The time from treatment initiation until death as a result of any cause
Time frame: 30 Months
Clinical Benefit Rate (CBR) at 16 Weeks
This will include sum of confirmed Complete plus Partial Responses plus stable disease at 16 weeks on treatment
Time frame: 30 Months
Clinical Benefit Rate (CBR) at 24 Weeks
This will include sum of confirmed Complete plus Partial Responses plus stable disease at 24 weeks on treatment
Time frame: 30 Months
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