Lisata Therapeutics has completed the enrolment of subjects for the Phase Ib/IIa CENDIFOX study to assess its investigational drug, certepetide, in conjunction with FOLFIRINOX-based therapies across multiple cancer types.
These include pancreatic, colon, and appendiceal cancers. The enrolment has been completed in all three cohorts of the trial.
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Led by Dr Anup Kasi, the trial is being conducted at The University of Kansas (KU) Cancer Center.
Certepetide is being supplied by the company for the open-label trial. It is designed to assess the therapeutic effects and safety of combining certepetide and neoadjuvant FOLFIRINOX regimens, with or without panitumumab.
A total of 66 subjects have been enrolled in the trial, with 35 subjects having resectable and borderline resectable pancreatic cancer, 18 with high-grade colon and appendiceal cancer with peritoneal metastasis, and with 13 oligo-metastatic colon cancer.
The funding for this investigator-initiated trial was provided by the KU Cancer Center.
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By GlobalDataLisata Therapeutics is set to gain valuable insights from the trial, including pre-treatment and post-treatment tumour tissue data for immune profiling and monitoring long-term patient outcomes.
Lisata Therapeutics Research and Development executive vice-president and chief medical officer Kristen Buck said: “The successful enrolment of all three cohorts in the CENDIFOX trial is another significant milestone, bringing us closer to validating certepetide’s potential as a transformative treatment for advanced solid tumours.
“By addressing the unmet medical needs of patients with solid tumours, we aim to improve patient outcomes and augment the standard-of-care paradigm. We are excited about the progress of the CENDIFOX trial and eagerly anticipate reporting the results from this important study in 2025.”
An internalising RGD cyclic peptide product, certepetide is designed to selectively activate the C-end rule active transport mechanism, enhancing the penetration and accumulation of systemically co-administered agents in the tissue.
In January this year, the company began a Phase IIa trial of LSTA1 for individuals with newly diagnosed glioblastoma multiforme (GBM).
