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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01260545 | Study of CA-18C3 in Subjects With Advanced Hematologic Malignancies | PHASE1 | COMPLETED | 14 | — | — | Apr 30, 2011 | Sep 30, 2012 | Feb 16, 2021 | 1 | United States |
To determine the toxicities, including the dose limiting toxicity and maximum tolerated dose of CA-18C3 when administered intravenously at up to 3.75 mg/kg twice monthly in subjects with hematologic malignancies. To determine the pharmacokinetics (PK) of CA-18C3 following study drug administration
| Arm | Type | Description |
|---|---|---|
| Infusion | EXPERIMENTAL | A standard 3+3 design will be employed to determine maximum tolerated dose |
| Name | Type | Description |
|---|---|---|
| CA-18C3 | DRUG | 2.5 mg/kg, 3.75 mg/kg IV (in the vein) on Day 1 of each 14 day cycle until the subject is no longer benefiting clinically or unacceptable toxicity occurs. |
Inclusion Criteria: * Male or female subjects age ≥ 18 years of age * Subject must have a relapsed/refractory leukemia for which no standard therapies are anticipated to result in a durable remission. Subjects with previously treated high-risk myelodysplasia (MDS) (Intermediate 2 or high-risk by IP...