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CA-18C3 · 1 trial · 1 indication
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...
CA-18C3 is an investigational small molecule being studied for the treatment of hematologic malignancies, which are cancers of the blood, bone marrow, and lymph nodes. It is currently in Phase 1 clinical development and has not been approved by the FDA.
CA-18C3 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 1 clinical development for hematologic malignancies.
CA-18C3 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 study of CA-18C3 in subjects with advanced hematologic malignancies has been completed.
CA-18C3 has one completed clinical trial, identified as NCT01260545, titled "Study of CA-18C3 in Subjects With Advanced Hematologic Malignancies." This Phase 1 study enrolled 14 participants in the United States and included adults aged 18 years and older.
CA-18C3 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of hematologic malignancies. A Phase 1 study has been completed, but the drug remains under investigation and has not been approved for commercial use.