Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810), in Treating Refractory Microsatellite Stable Colorectal Cancer

This phase I/II trial studies the side effects and best dose of pidnarulex when given together with cemiplimab and to see how well it works in treating patients with microsatellite stable (MSS) colorectal cancer (CRC) that does not respond to treatment (refractory). Pidnarulex may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pidnarulex with cemiplimab may be safe,

Trial Details

NCT ID
NCT07147231
Phase
PHASE1 / PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Cemiplimab
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Pidnarulex
Locations (sample)
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Baltimore, Maryland, United States|39.29038,-76.61219

Key Eligibility Criteria

  • Patients must have pathologically confirmed colorectal adenocarcinoma that is unresectable and/or metastatic and for which standard curative or pal…
  • Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
  • Patients must have pathologically confirmed proficient mismatch repair proteins (pMMR) and/or not microsatellite-high status (non-MSI-H). This may …
  • Phase 2 patients must have at least one liver metastasis at study entry (by imaging and/or histology, per investigator assessment); this metastasis…

For full eligibility, visit ClinicalTrials.gov.

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