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NCT04363801 · ClinicalTrials.gov registry record · Phase 2
A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal Cancer
A Phase 2 study, sponsored by Leap Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 247
- Enrollment target
NCT04363801: Clinical Trial Phase 2 study, sponsored by Leap Therapeutics.
NCT04363801 is a Phase 2 study that was terminated before completion, run by Leap Therapeutics. The registered enrollment target is 247 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04363801, a Phase 2 study, was terminated before completion, sponsored by Leap Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 247 participants
- Enrollment target
Study 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
Primary Outcome
Number of subjects with adverse drug reactions and toxicities as assessed by CTCAE v5.0 CAPOX (capecitabine + oxaliplatin) in patients with inoperable, locally advanced or metastatic G/GEJ adenocarcinoma.
Interventions
- DRUG DKN-01 300mg
- DRUG DKN-01 600mg
- DRUG DKN-01 400mg
- DRUG Tislelizumab 200mg
- DRUG Tislelizumab 400mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 2 |
Why NCT04363801 stopped before completion
NCT04363801 is an interventional study that assigns participants to a tested intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% higher).
The record links to 0 conditions, and to 5 interventions - of which DKN-01 300mg is the first listed.
NCT04363801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04363801 about?
NCT04363801 is a clinical study titled "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
What is the current status of trial NCT04363801?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 247 participants. The study started on 2020-07-29. Estimated completion is 2025-03-31.
What interventions are being tested in trial NCT04363801?
The interventions under investigation include: DKN-01 300mg (DRUG), DKN-01 600mg (DRUG), DKN-01 400mg (DRUG), Tislelizumab 200mg (DRUG), Tislelizumab 400mg (DRUG).
Who is sponsoring clinical trial NCT04363801?
This trial is sponsored by Leap Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04363801's enrollment target sits among peer trials
247 234th of 2000 higher than 1,767 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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