NCT05743621

Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer

Recruiting now Phase 1 Last updated 21 November 2025

What this trial tests

Phase 1 trial testing TVB-2640 in Prostatic Neoplasms, Castration-Resistant in 30 participants. Currently enrolling.

Timeline

20 November 2023

Primary endpoint
25 January 2027

25 January 2029

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	20 November 2023
Primary completion	25 January 2027
Estimated completion	25 January 2029
Sites	1 location across United States

Drugs / interventions tested

• TVB-2640 — full drug profile →
• Enzalutamide (enzalutamide) — full drug profile →

Conditions studied

• Prostatic Neoplasms, Castration-Resistant — all drugs for Prostatic Neoplasms, Castration-Resistant →

Sponsor

Weill Medical College of Cornell University

Who can join

18 and older, male only, with Prostatic Neoplasms, Castration-Resistant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine what effects (good and bad) Enzalutamide and TVB-2640 have in the treatment of prostate cancer whose prostate cancer has spread to other parts of their body and that has not gotten better with previous treatment. This study is a Phase I clinical trial. Phase I clinical trials test the side effects of an investigational drug or an investigational combination with another drug. "Investigational" means that the drug is still being studied and research doctors are trying to find out more about it. Although Enzalutamide is already being used to treat men with prostate cancer, combining Enzalutamide with TVB-2640 together in patients with prostate cancer is considered experimental. This research study is being done because additional effective treatments are needed for prostate cancer that has spread and is growing despite hormone suppression. By doing this study, the investigators hope to learn if combining Enzalutamide with TVB-2640 can be done safely. Participation in this research will last about 12 to 24 months after enrollment.

Publications & conference data

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

1. Tumor biomarkers for diagnosis, prognosis and targeted therapy.
   Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
2. Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
   Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
3. Cancer cell metabolism and antitumour immunity.
   De Martino M, Rathmell JC, Galluzzi L, Vanpouille-Box C. · · 2024 · cited 183× · PMID 38649722 · DOI 10.1038/s41577-024-01026-4
4. Energy metabolism in health and diseases.
   Liu H, Wang S, Wang J, Guo X, et al · · 2025 · cited 178× · PMID 39966374 · DOI 10.1038/s41392-025-02141-x
5. Cancer metabolism and carcinogenesis.
   Yang J, Shay C, Saba NF, Teng Y. · · 2024 · cited 73× · PMID 38287402 · DOI 10.1186/s40164-024-00482-x
6. Emerging targets in lipid metabolism for cancer therapy.
   Terry AR, Hay N. · · 2024 · cited 68× · PMID 38762377 · DOI 10.1016/j.tips.2024.04.007
7. Lipid metabolism reprogramming in endometrial cancer: biological functions and therapeutic implications.
   Wang X, Li Y, Hou X, Li J, et al · · 2024 · cited 22× · PMID 39256811 · DOI 10.1186/s12964-024-01792-7
8. Lactate as Key Metabolite in Prostate Cancer Progression: What Are the Clinical Implications?
   Chetta P, Sriram R, Zadra G. · · 2023 · cited 22× · PMID 37444583 · DOI 10.3390/cancers15133473