NCT04681248

Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Leap Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

An Expanded Access Protocol for use of DKN-01 for the treatment of advanced solid tumors.

Detailed description

This is a intermediate-size Expanded Access Protocol (EAP). Patients who were receiving DKN-01 in a parent study at the time of completion of the parent study, and are, in the opinion of the Investigator and Sponsor, suitable candidates for continued study drug treatment are eligible for participation in the current EAP. In this EAP, previously treated patients will receive DKN-01 at the same dose and schedule as at the time of completion of the parent study. Furthermore, patients who received DKN-01 in combination in the parent study will continue to receive the same combination agent at the same dose and schedule in the EAP. DKN-01 naïve patients, with advanced solid tumors not eligible for enrollment to a DKN-01 clinical study but whom, in the opinion of the treating oncologist, would potentially receive benefit from treatment with DKN-01 while it is an investigational drug may be eligible for enrollment in this EAP. Eligible DKN-01 naïve patients with Wnt activating mutations will receive DKN-01 as monotherapy, administered intravenously on Day 1 of each 21-day cycle at a dose of 600 mg, with a loading dose of 600 mg of DKN-01 administered on Day 15 of Cycle 1 only.

Conditions

• Esophageal Neoplasm
• Adenocarcinoma of the Gastroesophageal Junction
• GastroEsophageal Cancer
• Squamous Cell Carcinoma
• Gastric Adenocarcinoma
• Endometrial Cancer
• Uterine Cancer
• Ovarian Cancer
• Carcinosarcoma
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	DKN-01	Administered by IV infusion

Timeline

• First posted: 2020-12-23
• Last updated: 2025-08-03

Locations

5 sites across 1 country: United States