NCT05034627

Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

Active, enrolled Phase 1 Last updated 28 November 2025

What this trial tests

Phase 1 trial testing Biopsy in Locally Advanced Pancreatic Adenocarcinoma in 15 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

9 August 2022

Primary endpoint
16 December 2025

1 October 2026

Quick facts

Lead sponsor	OHSU Knight Cancer Institute
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	9 August 2022
Primary completion	16 December 2025
Estimated completion	1 October 2026
Sites	1 location across United States

Drugs / interventions tested

• Biopsy — full drug profile →
• Calaspargase Pegol-mknl — full drug profile →
• Cobimetinib (cobimetinib) — full drug profile →

Conditions studied

• Locally Advanced Pancreatic Adenocarcinoma — all drugs for Locally Advanced Pancreatic Adenocarcinoma →
• Metastatic Pancreatic Adenocarcinoma — all drugs for Metastatic Pancreatic Adenocarcinoma →
• Stage II Pancreatic Cancer AJCC v8 — all drugs for Stage II Pancreatic Cancer AJCC v8 →
• Stage IIA Pancreatic Cancer AJCC v8 — all drugs for Stage IIA Pancreatic Cancer AJCC v8 →

Sponsor

OHSU Knight Cancer Institute

Who can join

18 and older, any sex, with Locally Advanced Pancreatic Adenocarcinoma or Metastatic Pancreatic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial tests the safety, side effects, and best dose of calaspargase pegol-mknl in combination with cobimetinib in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Cobimetinib attacks a protein called MEK that has been known to stimulate cells that promote the growth of cancer cells in the body. Calaspargase pegol-mknl is an enzyme that converts the amino acid L-asparagine into aspartic acid and ammonia. Many types of cancer cell rely on the amino acid L-asparagine, and depleting this amino acid with calaspargase pegol-mknl starves cancer cells of this nutrient. Attacking the MEK protein with cobimetinib is thought to further prevent cancer cells from using this amino acid, causing them to die. Giving calaspargase pegol-mknl in combination with cobimetinib may help control the disease in patients with pancreatic cancer.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. PEGylated therapeutics in the clinic.
   Gao Y, Joshi M, Zhao Z, Mitragotri S. · · 2024 · cited 133× · PMID 38193121 · DOI 10.1002/btm2.10600
2. Emerging mechanisms and promising approaches in pancreatic cancer metabolism.
   Wu H, Fu M, Wu M, Cao Z, et al · · 2024 · cited 48× · PMID 39090116 · DOI 10.1038/s41419-024-06930-0
3. Inhibition of the RAF/MEK/ERK Signaling Cascade in Pancreatic Cancer: Recent Advances and Future Perspectives.
   Adamopoulos C, Cave DD, Papavassiliou AG, Papavassiliou AG. · · 2024 · cited 19× · PMID 38338909 · DOI 10.3390/ijms25031631
4. Emerging kinase inhibitors for the treatment of pancreatic ductal adenocarcinoma.
   Rudloff U. · · 2022 · cited 9× · PMID 36250721 · DOI 10.1080/14728214.2022.2134346
5. Targeting <i>KRAS</i> in pancreatic adenocarcinoma: Progress in demystifying the holy grail.
   Elhariri A, Alhaj A, Ahn D, Sonbol MB, et al · · 2023 · cited 5× · PMID 37700806 · DOI 10.5306/wjco.v14.i8.285
6. CASPER: A Phase I trial combining calaspargase pegol-mnkl and cobimetinib in pancreatic cancer.
   Lopez CD, Kardosh A, Chen EY, Pegna G, et al · · 2024 · cited 2× · PMID 39378065 · DOI 10.1080/14796694.2024.2395235
7. Metabolic plasticity in pancreatic ductal adenocarcinoma progression and response to treatment.
   Ma J, Bhardwaj V, Lobie PE, Pandey V. · · 2026 · PMID 41904584 · DOI 10.1186/s12943-026-02620-x