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

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ClinicalTrials.gov Identifier: NCT04681248
Expanded Access Status : Available
First Posted : December 23, 2020
Last Update Posted : September 29, 2023
Sponsor:
Information provided by (Responsible Party):
Leap Therapeutics, Inc.

Tracking Information
First Submitted Date December 18, 2020
First Posted Date December 23, 2020
Last Update Posted Date September 29, 2023
 
Descriptive Information
Brief Title Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors
Brief 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.
Study Type Expanded Access
Expanded Access Type Intermediate-size Population
Intervention Drug: DKN-01
Administered by IV infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: Leap Therapeutics, Inc. 617-714-0360 EarlyAccess@leaptx.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04681248
Current Responsible Party Leap Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor Leap Therapeutics, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Leap Therapeutics, Inc.
Verification Date September 2023