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    DRUG:

    Asparlas (calaspargase pegol-mknl)

    i
    Other names: SHP663, EZN-2285, SC-PEG E. coli L-asparaginase, succinimidyl carbonate monomethoxypolyethylene glycol E. coli L-asparaginase, Cal-PEG, SC-PEG2100 E. coli L-asparaginase, S95015, CalPEG, Cal PEG, EZN2285, EZN 2285, S-95015, S 95015, SHP-663, SHP 663
    Company:
    Leadiant Biosci, Servier, Takeda
    Drug class:
    Asparagine depleter, Aspartate-ammonia ligase inhibitor
    Related drugs:
    3d
    AALL1621: Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=80, Recruiting, Children's Oncology Group | Trial completion date: Mar 2026 --> Dec 2026 | Trial primary completion date: Mar 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    CD22 (CD22 Molecule)
    |
    cytarabine • cyclophosphamide • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • leucovorin calcium • Oncaspar liquid (pegaspargase) • Asparlas (calaspargase pegol-mknl) • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Starasid (cytarabine ocfosfate)
    12d
    Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration (clinicaltrials.gov)
    P=N/A, N=20, Not yet recruiting, Mayo Clinic | Initiation date: Nov 2025 --> Feb 2026
    Trial initiation date
    |
    Asparlas (calaspargase pegol-mknl)
    1m
    Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration (clinicaltrials.gov)
    P=N/A, N=20, Not yet recruiting, Mayo Clinic
    New trial
    |
    Asparlas (calaspargase pegol-mknl)
    1m
    CASPER: Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, OHSU Knight Cancer Institute | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Cotellic (cobimetinib) • Asparlas (calaspargase pegol-mknl)
    2ms
    SPARK-ALL: Calaspargase Pegol in Adults With ALL (clinicaltrials.gov)
    P2/3, N=122, Active, not recruiting, Institut de Recherches Internationales Servier | Trial primary completion date: Feb 2026 --> Mar 2025
    Trial primary completion date
    |
    Asparlas (calaspargase pegol-mknl)
    2ms
    Asparagine Synthetase promoter hypermethylation is required, but not sufficient, for sensitivity to Asparlas in patient-derived models of hepatocellular carcinoma. (PubMed, Eur J Pharmacol)
    However, when a panel of patient derived xenograft models representing a range of pASNSmet levels was tested we found that high pASNSmet levels were required but not necessarily sufficient to confer sensitivity to treatment with Asparlas. Collectively, these results are in support of ASNS promoter hypermethylation as a targetable phenotype but indicate that pASNSmet alone is not a viable biomarker of this phenotype, and that significant advancements in our understanding of the underlying biology may be required before asparaginase-depleting therapy can be successfully implemented clinically in HCC.
    Journal
    |
    ASNS (Asparagine synthetase)
    |
    Asparlas (calaspargase pegol-mknl)
    2ms
    A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy) (clinicaltrials.gov)
    P2, N=22, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Venclexta (venetoclax) • decitabine • Asparlas (calaspargase pegol-mknl)
    2ms
    Venetoclax Basket Trial for High Risk Hematologic Malignancies (clinicaltrials.gov)
    P1, N=13, Active, not recruiting, Andrew E. Place, MD | Recruiting --> Active, not recruiting | N=92 --> 13
    Enrollment closed • Enrollment change • Pan tumor
    |
    FLT3 (Fms-related tyrosine kinase 3) • ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • BCL2 (B-cell CLL/lymphoma 2) • KMT2A (Lysine Methyltransferase 2A) • IKZF1 (IKAROS Family Zinc Finger 1)
    |
    KMT2A rearrangement • ABL1 fusion
    |
    Venclexta (venetoclax) • cytarabine • doxorubicin hydrochloride • azacitidine • vincristine • leucovorin calcium • Asparlas (calaspargase pegol-mknl) • dexrazoxane
    2ms
    AALL2331: Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL) (clinicaltrials.gov)
    P2/3, N=1708, Not yet recruiting, Children's Oncology Group | Initiation date: Sep 2025 --> Mar 2026
    Trial initiation date
    |
    cytarabine • bortezomib • doxorubicin hydrochloride • cyclophosphamide • methotrexate • Darzalex (daratumumab) • vincristine • daunorubicin • Oncaspar liquid (pegaspargase) • nelarabine • Asparlas (calaspargase pegol-mknl) • thioguanine • Hemady (dexamethasone tablets) • Purixan (mercaptopurine oral suspension) • Starasid (cytarabine ocfosfate)
    3ms
    Exploring the Effect of Calaspargase Pegol on the Coagulation System in Pediatric Acute Lymphoblastic Leukemia (ALL) Patients: Pilot Study (clinicaltrials.gov)
    P=N/A, N=15, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Asparlas (calaspargase pegol-mknl)
    4ms
    Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma (clinicaltrials.gov)
    P1, N=40, Recruiting, New York Medical College | Trial completion date: Dec 2026 --> Dec 2028 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • doxorubicin hydrochloride • cyclophosphamide • ifosfamide • etoposide IV • Adcetris (brentuximab vedotin) • prednisone • Asparlas (calaspargase pegol-mknl)
    4ms
    CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov)
    P1, N=7, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Rituxan (rituximab) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Asparlas (calaspargase pegol-mknl)