TrialSignal
Clinical trial intelligence report
2157GCCC: a Phase I Trial of Calaspargase Pegol-mknl in Combination with High Dose Cytarabine and Idarubicin in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jul 28, 2026
Report code
NCT04953780-Jul 28, 2026
NCT ID
NCT04953780
Status
ACTIVE_NOT_RECRUITING
Phase
Phase 1
Sponsor
West Virginia University
Executive brief
Investment-Ready Snapshot
The Phase 1 trial of Calaspargase Pegol-mknl in combination with high-dose Cytarabine and Idarubicin is aimed at establishing the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) for adult patients with newly diagnosed AML. Given the high unmet need in AML treatment, particularly for patients who are refractory to standard therapies, successful outcomes could position Calaspargase Pegol-mknl as a novel therapeutic option in a competitive market. The trial is sponsored by West Virginia University, and the results could have significant implications for further development and potential commercialization, especially if the drug demonstrates a favorable safety and efficacy profile compared to existing therapies.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT04953780
Indication
Acute Myeloid Leukemia
Modality
small molecule
Target
Calaspargase Pegol-mknl targets asparagine metabolism by depleting plasma asparagine levels, which is critical for the survival of certain leukemic cells, particularly in Acute Myeloid Leukemia (AML).
Intervention
Calaspargase pegol-mknl
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.