Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04596150
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2020-10-02
Brief Title:
Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer
Sponsor:
CytomX Therapeutics
Organization:
CytomX Therapeutics
Study Overview
Official Title:
A Phase 2 Open-Label Study to Evaluate the Safety and Antitumor Activity of Praluzatamab Ravtansine CX-2009 in Advanced HR-PositiveHER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination With Pacmilimab CX-072 in Advanced Triple-Negative Breast Cancer CTMX-2009-002
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 2 clinical study in advanced metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone ReceptorHR positiveHER2 negative breast cancer and in TNBC and evaluate CX-2009CX-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 v11 for the first 48 weeks and every 12 weeks thereafter
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 v11 for the first 48 weeks and every 12 weeks thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004618-36 | EUDRACT_NUMBER | None | None |