NCT04363801

A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal Cancer

A Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients With Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (DisTinGuish)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Leap Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Detailed description

This is a Phase 2 open-label, multicenter study to be conducted concurrently in 3 Parts (Parts A, B, and C). Approximately 232 patients aged 18 years or older with inoperable, histologically confirmed locally advanced or metastatic Gastric or Gastroesophageal Junction (G/GEJ) adenocarcinoma with measurable disease (RECIST v1.1) requiring therapy will be enrolled in the study. Part A and B are designed to evaluate safety, tolerability, and efficacy of the combination therapy of intravenous (IV) DKN-01 and tislelizumab ± CAPOX in G/GEJ adenocarcinoma patients. Treatment continues in repeating 21-day cycles until patient meets criteria for discontinuation or is no longer deriving clinical benefit. Two doses of DKN-01 will be evaluated in Part B (Part B1 and Part B2). Part C is the open-label, randomized, controlled, 2-arm portion of the study to evaluate the efficacy and safety of tislelizumab + chemotherapy regimen (CAPOX or mFOLFOX6) ± DKN-01 in adult patients with inoperable, histologically confirmed locally advanced or metastatic G/GEJ adenocarcinoma with measurable disease (RECIST v1.1) requiring therapy. Approximately 160 patients will be randomized in a 1:1 ratio to receive either DKN-01 in combination with tislelizumab and chemotherapy regimen (CAPOX or mFOLFOX6) (n=80) or tislelizumab in combination with chemotherapy regimen (CAPOX or mFOLFOX6) (n=80).

Conditions

• Gastric Cancer
• Gastric Adenocarcinoma
• GastroEsophageal Cancer

Interventions

Type	Name	Description
DRUG	DKN-01 300mg	Administered by IV infusion
DRUG	DKN-01 600mg	Administered by IV infusion
DRUG	DKN-01 400mg	Administered by IV infusion
DRUG	Tislelizumab 200mg	Administered by IV infusion
DRUG	Tislelizumab 400mg	Administered by IV infusion
DRUG	Oxaliplatin	Administered by IV infusion
DRUG	Capecitabine 1000mg/ m2 twice daily (BID)	Administered orally
DRUG	Leucovorin Calcium	Administered by IV infusion
DRUG	Fluorouracil	Administered by IV infusion

Timeline

• Start date: 2020-07-29
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2020-04-27
• Last updated: 2025-10-09
• Results posted: 2025-10-09

Locations

48 sites across 3 countries: United States, Germany, South Korea

Regulatory

• FDA-regulated drug study