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...