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...
Top 20 of 87 competitors
CDX-011, also known as glembatumumab vedotin, is an investigational drug being studied for the treatment of breast cancer, specifically metastatic gpNMB over-expressing triple negative breast cancer. It is a small molecule developed by Celldex Therapeutics for use in oncology.
CDX-011 targets gpNMB, a protein that is over-expressed in certain types of breast cancer. By targeting gpNMB, the drug aims to deliver a cytotoxic agent to cancer cells that express this protein, potentially leading to their destruction.
CDX-011 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLDX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced breast cancer.
CDX-011 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in patients with advanced gpNMB-expressing breast cancer and another in patients with metastatic, gpNMB over-expressing triple negative breast cancer. The drug is investigational and not yet approved.
CDX-011 has been studied in two completed Phase 2 clinical trials. The first, NCT01156753, enrolled 120 patients with advanced gpNMB-expressing breast cancer in the United States. The second, NCT01997333, enrolled 327 patients with metastatic, gpNMB over-expressing triple negative breast cancer across multiple countries including the US, Australia, and several European nations.
Yes, CDX-011 is also known as glembatumumab vedotin. The drug is referred to by both names in clinical research, with glembatumumab vedotin being the generic name and CDX-011 the development code.