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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01460134 | A Study of CDX-1127 (Varlilumab) in Patients With Select Solid Tumor Types or Hematologic Cancers | PHASE1 | COMPLETED | 90 | — | — | Oct 1, 2011 | Oct 16, 2017 | Jan 31, 2018 | 10 | United States |
Analysis of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of CDX-1127.
| Arm | Type | Description |
|---|---|---|
| Hematologic Malignancies (Dose Escalation) | EXPERIMENTAL | B-Cell Enrollment COMPLETED T-Cell Enrollment COMPLETED |
| Solid tumors (Dose Escalation; COMPLETED) | EXPERIMENTAL | - |
| Solid Tumors (Expansion Phase; COMPLETED) | EXPERIMENTAL | Several expansion cohorts of up to 15 patients each are planned, including melanoma and renal cell carcinoma. |
| Hematologic Malignancies (COMPLETED) | EXPERIMENTAL | Several expansion cohorts of up to 15 patients each are planned, including Hodgkin lymphoma. |
| Name | Type | Description |
|---|---|---|
| CDX-1127 | DRUG | Patients will initially receive a single dose of CDX-1127, followed by a 28-day observation period and a Multi-Dose Phase (one "cycle" of 4 weekly doses of CDX-1127). All patients with stable disease who do not experience a DLT or start alternate anti-cancer treatments may then be eligible for a Retreatment Phase (up to 4 additional "cycles"). Patients with confirmed partial response or complete response will be followed for response duration and may be eligible for additional cycles of treatment at the time of relapse/progression. The dose of CDX-1127 given for the Dose Escalation phase will depend on the cohort each patient is assigned to, and will range between 0.1 and 10.0 mg/kg of CDX-1127. |
Inclusion Criteria: Among other criteria, patients must meet the following conditions to be eligible for the study: 1. 18 years of age or older. 2. Body Weight ≤ 120 kg. 3. Histologic diagnosis of either a B-cell or T-cell hematologic malignancy known to express CD27 or one of the following solid ...