Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01346358 | A Study of IMC-CS4 in Subjects With Advanced Solid Tumors | PHASE1 | COMPLETED | 52 | — | — | Jun 15, 2011 | May 31, 2018 | Sep 19, 2024 | 6 | United States |
Pharmacokinetics (PK) - Maximum concentration (Cmax) of IMC-CS4.
Pharmacokinetics - Minimum concentration (Cmin) of IMC-CS4.
Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4.
Pharmacokinetics - Volume of distribution at steady state (Vss) of IMC-CS4.
Pharmacokinetics -Clearance (Cl) of IMC-CS4.
| Arm | Type | Description |
|---|---|---|
| IMC-CS4 Weight Based Dosing | EXPERIMENTAL | Participants received 2.5 mg/kg once weekly (QW), 0.3 mg/kg QW, 0.6 mg/kg QW, 1.25 mg/kg every two weeks (Q2W) and1.25 mg/kg QW of IMC CS4 by intravenous infusion in Part A. |
| IMC-CS4 Non-Weight Based Dosing | EXPERIMENTAL | Participants received 100 mg QW, 100 mg QW on weeks 1, 2, 4 and 5 and 150 mg QW of IMC CS4 by intravenous infusion in Part B. |
| Name | Type | Description |
|---|---|---|
| IMC-CS4 | BIOLOGICAL | - |
Inclusion Criteria: * Subject has histologic or cytologic confirmation of advanced solid tumors that is refractory to standard therapy or for which no standard therapy is available * Subject has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) V...