A Phase 1 Study of Debio 0123 in People With Advanced Gynecologic Cancers


Full Title

A Phase 1, Dose-Finding Study of Debio 0123 as Monotherapy in Adult Patients with Advanced Solid Tumors, followed by an Expansion Part to Assess Safety and Preliminary Anti-Tumor Activity


Researchers are assessing Debio 0123 to treat different kinds of gynecologic cancers. In part 1 of the study, they will find the best dose of Debio 0123 to treat uterine serous carcinoma. The people in this study have uterine serous carcinoma that keeps growing even after treatment.

In part 2 of the study, researchers will see how well Debio 0123 works against three types of cancer that keep growing after treatment:

  • High-grade epithelial ovarian cancer
  • Primary peritoneal cancer
  • Fallopian tube cancer

The people in this part of the study have cancers that make a high amount of a protein called cyclin E1.

Debio 0123 prevents cancer cells from repairing their damaged DNA (genetic material). By preventing this repair, Debio 0123 may kill cancer cells and reduce tumor size. It is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have uterine serous carcinoma, high-grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that keeps growing after treatment.
  • Have a cancer that makes high amounts of cyclin E1 (ovarian, peritoneal, or fallopian tube cancer), if you are in part 2 of the study.
  • Have completed prior treatments at least 4 weeks before taking Debio 0123.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.


For more information or to see if you can join this study, please call Dr. Maria Rubinstein at 646-888-6954.




Phase I (phase 1)



ClinicalTrials.gov ID