Phase 2
N=327
Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer
Metastatic gpNMB Over-expressing Triple Negative Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01997333 ↗Enrolled (actual)
327
Serious AEs
29.5%
Results posted
Mar 2019
Primary outcome: Primary: Progression Free Survival (PFS) — 2.8; 2.9 months — p=0.761
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CDX-011 (Drug); Capecitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celldex Therapeutics
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
2.8; 2.9 | 0.761 |
| SECONDARY Objective Response Rate (ORR) |
21; 26 | 0.264 |
| SECONDARY Duration of Response |
4.2; 2.8 | — |
| SECONDARY Overall Survival |
8.7; 8.9 | 0.726 |
| SECONDARY Adverse Events (AE) |
92; 211; 84; 204; 7; 7 | — |
| SECONDARY Pharmacokinetics (PK) |
58.6; 49.4; 0.0015 | — |
Summary
The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.
Eligibility Criteria
Inclusion Criteria
Among other criteria, patients must meet all of the following conditions to be eligible for the study:
- Diagnosed with metastatic (i.e., cancer that has spread) TNBC
- minimal or no expression of estrogen and progesterone receptors (ER/PR) <10% of cells positive by immunohistochemistry
- HER 2 staining 0 or 1+ by IHC or copy number <4.0 signals/cell
- Documented progression of disease based on radiographic, clinical or pathologic assessment during or subsequent to the last anticancer regimen received.
- Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease setting to a central laboratory for analysis.
- Received no more than two prior chemotherapy treatments for advanced (locally advanced/recurrent or metastatic) breast cancer.
- Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or Doxil) if clinically indicated and a taxane (eg: Taxol).
- ECOG performance status of 0 - 1.
- Adequate bone marrow, liver and renal function.
Exclusion:
Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:
- Progression/recurrence of breast cancer during or within 3 months of completion of neoadjuvant or adjuvant chemotherapy.
- Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.
- Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
- Significant cardiovascular disease.
- Previously received capecitabine and discontinued due to progression or intolerance; previously received CDX-011 or other MMAE containing agents.
- Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.
- Chronic use of systemic corticosteroids.
Data sourced from ClinicalTrials.gov (NCT01997333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.