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NCT05480306 · ClinicalTrials.gov registry record · Phase 2

Phase 2 Study of DKN-01 in Colorectal Cancer

A Phase 2 study, sponsored by Leap Therapeutics.

Completed
Registry status
Phase 2
Development phase
188
Enrollment target

NCT05480306: Completed Phase 2 study, sponsored by Leap Therapeutics.

NCT05480306 is a Phase 2 study that has completed, run by Leap Therapeutics. The registered enrollment target is 188 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05480306, a Phase 2 study, has completed, sponsored by Leap Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
188 participants
Enrollment target

Study Summary

This is a Phase 2 randomized, open-label, two-part, multicenter study with a safety run-in to evaluate efficacy and safety of DKN-01 plus FOLFIRI/FOLFOX and bevacizumab versus standard of care (SOC) \[FOLFIRI/FOLFOX and bevacizumab\] as second-line treatment of advanced CRC patients.

Primary Outcome

PFS, as determined by the Investigator per RECIST v1.1 of DKN-01 plus SOC versus SOC.

Interventions

  • DRUG Bevacizumab
  • DRUG FOLFIRI
  • DRUG FOLFOX
  • DRUG DKN-01

Trial Details

FieldValue
Enrollment Target 188 participants
Start Date 2022-08-30
Est. Completion 2025-07-10
Phase Phase 2
Leap Therapeutics

10 total trials

What the finished NCT05480306 record still lists

NCT05480306 is an interventional study that assigns participants to a tested intervention. The registered 188 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 (41% higher).

The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.

NCT05480306 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05480306 about?

NCT05480306 is a clinical study titled "Phase 2 Study of DKN-01 in Colorectal Cancer". This is a Phase 2 randomized, open-label, two-part, multicenter study with a safety run-in to evaluate efficacy and safety of DKN-01 plus FOLFIRI/FOLFOX and bevacizumab versus standard of care (SOC) \[FOLFIRI/FOLFOX and bevacizumab\] as second-line treatment of advanced CRC patients.

What is the current status of trial NCT05480306?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 188 participants. The study started on 2022-08-30. Estimated completion is 2025-07-10.

What interventions are being tested in trial NCT05480306?

The interventions under investigation include: Bevacizumab (DRUG), FOLFIRI (DRUG), FOLFOX (DRUG), DKN-01 (DRUG).

Who is sponsoring clinical trial NCT05480306?

This trial is sponsored by Leap Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05480306's enrollment target sits among peer trials

188 356th of 2000 higher than 1,644 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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Source: ClinicalTrials.gov NCT05480306, the US trial registry maintained by the National Library of Medicine. NCT05480306 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.