Trials / Completed
CompletedNCT04596150
Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer
A Phase 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of Praluzatamab Ravtansine (CX-2009) in Advanced HR-Positive/HER2-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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- CytomX Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Neoplasms
- Breast Neoplasms
- Breast Neoplasms, Triple-Negative
- Breast Cancer
- Breast Neoplasms, Hormone Receptor Positive/HER2 Negative
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CX-2009 | Intravenous administration of the CX-2009 of 6 mg/kg administered every 3 weeks (Q3W) |
| DRUG | CX-072 | Intravenous administration of the CX-072 of 1200 mg administered every 3 weeks (Q3W) |
Timeline
- Start date
- 2020-12-29
- Primary completion
- 2023-06-02
- Completion
- 2023-06-02
- First posted
- 2020-10-22
- Last updated
- 2024-01-23
Locations
42 sites across 3 countries: United States, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04596150. Inclusion in this directory is not an endorsement.