Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CDX-011 · 2 trials · 2 indications
PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria.
The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.
| Arm | Type | Description |
|---|---|---|
| Capecitabine | ACTIVE_COMPARATOR | Capecitabine will be administered on Days 1 through 14 of each 21 day cycle. |
| Drug: CDX-011 | EXPERIMENTAL | CDX-011 administered as an intravenous infusion on Day 1 of each 21 day cycle. |
| CDX-011 | EXPERIMENTAL | - |
| "Investigator's Choice" chemotherapy | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CDX-011 | DRUG | - |
| Capecitabine | DRUG | - |
| "Investigator's Choice" chemotherapy | DRUG | Any of the following single-agent chemotherapy may be given at the discretion of the investigator, with a cycle length not to exceed four weeks: Capecitabine, Vinorelbine, Gemcitabine, Docetaxel, Paclitaxel, Albumin-bound paclitaxel, Doxorubicin HCL, Liposomal doxorubicin, Ixabepilone and Eribulin. |
Inclusion Criteria: Among other criteria, patients must meet all of the following conditions to be eligible for the study: 1. 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 immun...
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CDX-011 is an investigational drug being studied for the treatment of breast cancer, specifically metastatic gpNMB over-expressing triple negative breast cancer. It is in Phase 2 clinical development and is not yet approved by the FDA.
CDX-011 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLDX.
CDX-011 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials for this drug have been completed.
CDX-011 has been studied in two completed Phase 2 clinical trials. NCT01156753 enrolled 120 patients with advanced gpNMB-expressing breast cancer in the United States. NCT01997333 enrolled 327 patients with metastatic gpNMB over-expressing triple negative breast cancer across multiple countries.
Yes, CDX-011 is also known as glembatumumab vedotin. The clinical trial NCT01997333 is titled 'Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer.'