> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Leap Therapeutics Fast Track for Gastric Cancer Drug
- URL: https://www.fdaweb.com/leap-therapeutics-fast-track-for-gastric-cancer-drug/
- Published: 2020-09-24T12:00:00.000Z
- Updated: 2026-09-14T16:30:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147729

FDA has granted Leap Therapeutics a fast track designation for DKN-01 and its use in treating certain patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high Dickkopf-1 (DKK1) protein. DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of DKK1 protein, a modulator of Wnt/Beta-catenin signaling, according to the company. It is currently being evaluated in clinical trials for gastroesophageal, gynecologic, hepatobiliary, and prostate cancers. Earlier this month, the first patient was dosed in the company’s combination study of DKN-01 plus tislelizumab, BeiGene’s anti-PD-1 antibody, in patients with gastric or gastroesophageal junction cancer.