Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VE800 · 1 trial · 5 indications
Safety and tolerability of VE800 in combination with nivolumab: Number of Participants with Adverse Events
Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| VE800 combination treatment with nivolumab | EXPERIMENTAL | Subjects received 5 days of oral vancomycin, followed by daily VE800 in combination with nivolumab every 4 weeks. |
| Name | Type | Description |
|---|---|---|
| VE800 | BIOLOGICAL | VE800 is an orally administered (PO) live biotherapeutic product (LBP) consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under Good Manufacturing Practice (GMP) conditions. These strains were selected for their ability to induce an immune response. |
| Nivolumab | DRUG | Nivolumab is an approved medication that blocks antibodies for certain types of cancer. |
| Vancomycin Oral Capsule | DRUG | Vancomycin is an antibiotic used to treat or prevent infection. |
Partial Inclusion Criteria: * Patients with advanced or metastatic cancer who had received no more than 3 lines of prior systemic therapy for advanced/metastatic disease. * Histologically diagnosed advanced (unresectable) or metastatic cancer with at least one measurable lesion as per RECIST 1.1 * ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
VE800 is an investigational monoclonal antibody being studied for the treatment of metastatic cancer, including melanoma, gastric cancer, gastroesophageal junction adenocarcinoma, and colorectal cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
VE800 is a monoclonal antibody, but its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated in combination with nivolumab for its potential antitumor activity in patients with selected advanced or metastatic cancers.
VE800 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy.
VE800 is in Phase 1 clinical development. A Phase 1 study of VE800 in combination with nivolumab has been completed, with 56 patients enrolled. The drug remains investigational and has not received FDA approval for any indication.
VE800 has been studied in one clinical trial, NCT04208958, titled "Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer." This Phase 1, uncontrolled, non-randomized trial enrolled 56 patients in the United States and has been completed.
No, VE800 is not the same as nivolumab. VE800 is a separate investigational monoclonal antibody being developed by Bristol-Myers Squibb. In clinical trials, VE800 has been studied in combination with nivolumab, which is an approved PD-1 inhibitor, to evaluate their combined effects in treating advanced or metastatic cancers.