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mPEG-r-crisantaspase · 1 trial · 1 indication
To determine the Maximum Tolerated Dose following one single dose of mPEG-r-Crisantaspase when administered in a population of patients with relapsed or refractory hematological malignancies, as measured by Dose Limiting Toxicities.
| Arm | Type | Description |
|---|---|---|
| Intravenous Erwinia | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| mPEG-r-crisantaspase | BIOLOGICAL | IV infusion over 60 minutes of mPEG-r-crisantaspase given once every two or four weeks for two administrations. Based on non-clinical data, 500IU/m2 has been selected as the starting dose. Dose selection will proceed based upon safety and pharmacokinetic data but escalation will not exceed 100% |
Inclusion Criteria: * Patients with any relapsed or refractory hematological malignancy, for which standard curative or life prolonging treatment does not exist, or is no longer effective or tolerable. * For the following hematological malignancies, patients must have received at least: * Low gr...
mPEG-r-crisantaspase is an investigational drug 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 regulatory authorities.
mPEG-r-crisantaspase is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being evaluated for its potential role in treating hematologic malignancies, though the exact mechanism of action is not publicly detailed.
mPEG-r-crisantaspase is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol JAZZ. The company is conducting clinical research on this drug for the treatment of hematologic malignancies.
mPEG-r-crisantaspase is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The Phase 1 study has been completed, and the drug remains in early-stage clinical testing.
mPEG-r-crisantaspase has been studied in one completed Phase 1 clinical trial with the identifier NCT01551524. This trial, titled 'Phase I Study of mPEG-R-Crisantaspase Given IV,' enrolled 36 participants with hematologic malignancies in France. The study was open-label and uncontrolled.
mPEG-r-crisantaspase is a pegylated form of crisantaspase, an enzyme used in cancer treatment. The 'mPEG-r' prefix indicates that the drug is modified with polyethylene glycol and produced through recombinant technology. This modification may affect the drug's properties compared to the unmodified crisantaspase.