MedTrace Logo

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

NCT04363801 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2025-10-09

Study results available
· View outcomes & findings →

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

Conditions

Interventions

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

Sponsors & Collaborators

  • BeiGene

    collaborator INDUSTRY

  • Leap Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Cynthia Sirard, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2025-03-31
Completion
2025-03-31
FDA Drug
Yes

Countries

  • United States
  • Germany
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04363801 on ClinicalTrials.gov