CASPER: A Phase I trial combining calaspargase pegol-mnkl and cobimetinib in pancreatic cancer

Future Oncol. 2024;20(37):2915-2925. doi: 10.1080/14796694.2024.2395235. Epub 2024 Oct 8.

Abstract

Asparagine synthetase (ASNS) catalyzes the biosynthesis of asparagine from aspartate and glutamine. Cells lacking ASNS, however, are auxotrophic for asparagine. Use of L-asparaginase to promote asparagine starvation in solid tumors with low ASNS levels, such as pancreatic ductal adenocarcinoma (PDAC), is a rationale treatment strategy. However, tumor cell resistance to L-asparaginase has limited its clinical utility. Our preclinical studies show that RAS/MAPK signaling circumvents L-asparaginase-induced tumor killing, but L-asparaginase and MEK inhibition potentiated tumor killing; suggesting that this combination may provide meaningful clinical benefit to patients with PDAC. This Phase I trial (NCT05034627) will evaluate the safety and tolerability of the MEK inhibitor, cobimetinib, in combination with pegylated L-asparaginase, L calaspargase pegol-mknl, in patients with locally-advanced or metastatic PDAC.

Keywords: L-asparaginase; MEK inhibition; calaspargase pegol-mknl; cobimetinib; drug resistance; metabolic reprogramming; pancreatic cancer.

Plain language summary

[Box: see text].

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols* / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols* / pharmacology
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Asparaginase* / administration & dosage
  • Asparaginase* / pharmacology
  • Asparaginase* / therapeutic use
  • Aspartate-Ammonia Ligase / genetics
  • Aspartate-Ammonia Ligase / metabolism
  • Azetidines* / administration & dosage
  • Azetidines* / pharmacology
  • Azetidines* / therapeutic use
  • Carcinoma, Pancreatic Ductal* / drug therapy
  • Carcinoma, Pancreatic Ductal* / pathology
  • Female
  • Humans
  • Male
  • Pancreatic Neoplasms* / drug therapy
  • Pancreatic Neoplasms* / pathology
  • Piperidines* / pharmacology
  • Piperidines* / therapeutic use
  • Polyethylene Glycols*

Substances

  • Piperidines
  • Azetidines
  • Asparaginase
  • cobimetinib
  • Polyethylene Glycols
  • pegaspargase
  • Aspartate-Ammonia Ligase