NCT05070104

CPI-613 (Devimistat) in Combination With Modified FOLFIRINOX Plus Bevacizumab in Patients With Metastatic Colorectal Cancer

Withdrawn Phase 1 Last updated 13 September 2023

What this trial tests

Phase 1 trial testing CPI-613 in C04.588.274.476.411.307. Withdrawn.

Timeline

30 March 2023

Primary endpoint
1 March 2024

1 November 2024

Quick facts

Lead sponsor	Cornerstone Pharmaceuticals
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	30 March 2023
Primary completion	1 March 2024
Estimated completion	1 November 2024

Drugs / interventions tested

• CPI-613
• modified FFX — full drug profile →
• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →

Conditions studied

• C04.588.274.476.411.307 — all drugs for C04.588.274.476.411.307 →

Sponsor

Cornerstone Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with C04.588.274.476.411.307. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pre-clinical in vitro and in vivo data as well as early phase 1 clinical trials have shown that both hematologic and solid tumor cells are susceptible to single-agent cytotoxicity by CPI-613 (devimistat), consistent with its selective target of the altered form of mitochondrial energy metabolism in tumor cells, causing changes in mitochondrial enzyme activities and redox status, which lead to apoptosis, necrosis, and autophagy of tumor cells leading to the death of cancer cells. It is our hypothesis that CPI-613 (devimistat) will enhance the efficacy of mFOLFIRINOX plus Bevacizumab when given as a combination treatment. The study will follow a standard 3+3 design. Cohorts of three to six patients will be treated at each dose level until the MTD is defined.

Publications & conference data

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

1. Mitochondrial metabolism and cancer therapeutic innovation.
   Du H, Xu T, Yu S, Wu S, et al · · 2025 · cited 43× · PMID 40754534 · DOI 10.1038/s41392-025-02311-x
2. Blockage of Autophagy for Cancer Therapy: A Comprehensive Review.
   Hassan AMIA, Zhao Y, Chen X, He C. · · 2024 · cited 26× · PMID 39000565 · DOI 10.3390/ijms25137459
3. Inhibition of autophagy; an opportunity for the treatment of cancer resistance.
   Tonkin-Reeves A, Giuliani CM, Price JT. · · 2023 · cited 15× · PMID 37363731 · DOI 10.3389/fcell.2023.1177440
4. Role of mitochondria in physiological activities, diseases, and therapy.
   Wang L, Zhou X, Lu T. · · 2025 · cited 14× · PMID 40536597 · DOI 10.1186/s43556-025-00284-5
5. Bioenergetic alteration in gastrointestinal cancers: The good, the bad and the ugly.
   Chu YD, Chen CW, Lai MW, Lim SN, et al · · 2023 · cited 9× · PMID 37621758 · DOI 10.3748/wjg.v29.i29.4499