Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GC1008 Human Anti Transforming Growth Factor _Beta Monoclonal Antibody · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 - Part 1 | EXPERIMENTAL | Dose Group |
| 2 - Part 1 | EXPERIMENTAL | Dose Group |
| 3 - Part 1 | EXPERIMENTAL | Dose Group |
| 4 - Part 1 | EXPERIMENTAL | Dose Group |
| 5 - Part 1 | EXPERIMENTAL | Dose Group |
| 6 - Part 1 | EXPERIMENTAL | Dose Group |
| 1 (Part 2) | EXPERIMENTAL | - |
| 2 (part 2) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ) Monoclonal Antibody | BIOLOGICAL | 1 dose of 0.1 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 0.1 mg/kg IV (one dose every 14 days) |
| GC1008 Human Anti Transforming Growth Factor _Beta (TGFβ ) Monoclonal Antibody | BIOLOGICAL | 1 dose of 15.0 mg/kg IV followed by a 28 day observation period and then 3 additional doses of 15.0 mg/kg IV (one dose every 14 days) |
Inclusion Criteria: * In Part 1, Dose Escalation: Patients with histologically confirmed, locally advanced \& surgically inoperable or metastatic renal cell carcinoma or malignant melanoma are eligible. * In Part 2, Patient Expansion: Patients with histologically confirmed, locally advanced and sur...
GC1008 is an investigational monoclonal antibody developed by Sanofi. It was studied in a Phase 1 clinical trial for patients with renal cell carcinoma or malignant melanoma. It is designed to target transforming growth factor beta (TGFβ). The drug has completed one Phase 1 trial with 29 participants.
GC1008 was evaluated in a Phase 1 clinical trial for the treatment of renal cell carcinoma. The trial also included patients with malignant melanoma. It is an investigational therapy and has not been approved for any indication.
GC1008 targets transforming growth factor beta (TGFβ). It is a human monoclonal antibody that binds to TGFβ. This mechanism was explored in a Phase 1 trial for renal cell carcinoma and melanoma.
GC1008 is being developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi sponsored the Phase 1 trial of GC1008 in renal cell carcinoma and melanoma.
GC1008 is in Phase 1 clinical development. It has completed one Phase 1 trial. It is not approved by the FDA for any indication and remains investigational.
GC1008 was studied in a Phase 1 clinical trial, NCT00356460, titled "Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma." The trial enrolled 29 participants in the United States and is completed.