Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
gp75 DNA vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 0.1mg |
| 2 | EXPERIMENTAL | 0.5mg |
| 3 | EXPERIMENTAL | 2.0mg |
| 4 | EXPERIMENTAL | 4.0mg |
| 5 | EXPERIMENTAL | 8.0mg |
| Name | Type | Description |
|---|---|---|
| gp75 DNA vaccine | BIOLOGICAL | 6 patients will be enrolled in each of the 5 vaccination groups. Patients in vaccination groups 1-3 will receive a total of 5(1 mL) vaccinations. Patients assigned to vaccination group 4 will receive a total of 5 (2.0 mL) vaccinations administered as 2 1 mL injections. Patients assigned to vaccination group 5 will receive a total of 5 (4.0 mL or 8.0 mg)vaccinations administered as 4 1 mL injections per vaccination treatment Patients will receive gp75 DNA vaccinations every 3 weeks for 5 vaccinations. Injection sites will be given intramuscularly and rotated for each dose using all 4 limbs with the exception of a site that had the removal of lymph nodes. Progression to next higher dose level will be based on the 5\* patient safely completing the 2nd vaccination at the lower dose level. |
Inclusion Criteria: 1. The patient has a diagnosis of American Joint Commission on Cancer (AJCC) stage 111 or IV malignant melanoma. A patient who is free of disease after surgical resection of stage 111 or IV disease, but at high risk (defined as a primary tumor \>4 rnm, satellite or in-transit le...
The gp75 DNA vaccine is an investigational therapy being studied for the treatment of malignant melanoma, specifically in patients with stage III and IV disease. It is currently in Phase 1 clinical development and has not been approved for commercial use.
The gp75 DNA vaccine is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The therapy is in Phase 1 clinical development for malignant melanoma.
The gp75 DNA vaccine is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials for safety and efficacy in patients with malignant melanoma.
The gp75 DNA vaccine has been studied in one completed Phase 1 clinical trial, identified as NCT00034554, titled "Study of gp75 Vaccine in Patients With Stage III and IV Melanoma." The trial enrolled 31 participants in the United States and included adults aged 18 years and older.
The gp75 DNA vaccine is classified as a monoclonal antibody modality in its development program. It is being investigated as a potential treatment for malignant melanoma, with a completed Phase 1 trial involving 31 patients with stage III and IV disease.