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Phase 2 Study of DKN-01 in Colorectal Cancer

NCT05480306 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2025-08-03

No results posted yet for this 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.

Conditions

Interventions

DRUG

DKN-01

30 minute IV infusion (400mg) every two weeks with an additional loading dose in the first cycle of treatment

DRUG

FOLFIRI

90-min IV infusion of irinotecan, leucovorin, and fluorouracil followed by a continuous 46-hour infusion of fluorouracil every two weeks

DRUG

Bevacizumab

90-min IV infusion (5mg)

DRUG

FOLFOX

2 hour IV infusion of oxaliplatin, folinic acid, and fluorouracil followed by a continuous 46-hour infusion of fluorouracil every two weeks

Sponsors & Collaborators

  • Leap Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Cynthia Sirard · Leap Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2025-07-10
Completion
2025-07-10
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 NCT05480306 on ClinicalTrials.gov