Endometrial
cancer:

DKN-01 in endometrial cancer

Patients with endometrial cancer have a high frequency of mutations in a protein known as beta-catenin. These beta-catenin mutations are often driver mutations leading to high expression of DKK1, rapid disease progression, and poor outcomes. DKN-01 has demonstrated single agent activity in endometrial cancer patients, including a patient with a complete response. The activity of DKN-01 in endometrial cancer was strongest in patients whose tumors were expressing high levels of DKK1.

Ongoing clinical trials in endometrial cancer

Investigator-sponsored study

The investigator-sponsored trial of DKN-01 in combination with pembrolizumab (NCT05761951) is an open-label, Bayesian design, Phase 2 trial and will initially enroll 15 patients each into DKK1-high and DKK1-low cohorts. If the efficacy criteria is met in either or both of the 15 patient cohort(s), then the cohort(s) will be expanded by an additional 15 patients. The primary objective of the study is ORR. Secondary objectives include clinical benefit rate (CBR), PFS, OS, and DOR.

Posters/manuscripts for the endometrial cancer indication

• DKK1 is a predictive biomarker for response to DKN-01: Results of a phase 2 basket study in women with recurrent endometrial carcinoma
• Safety and Efficacy of a DKK1 Inhibitor (DKN-01) as Monotherapy or in Combination with Paclitaxel in Patients with Wnt Activated Recurrent Gynecologic Malignancies.
• Patients with recurrent epithelial endometrial cancers (EEC) demonstrated greater clinical benefit in biomarker-selected populations when treated with DKN-01 monotherapy.
• Response to anti-DKK1 Therapy in Uterine Carcinosarcoma: A Case Report