drugset
drugset / Trial / NCT05480306

Phase 2 Study of DKN-01 in Colorectal Cancer

NCT05480306 ↗

Phase 2 Completed 188 enrolled Leap Therapeutics, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-08-30
Primary completion
2025-07-10
Completion
2025-07-10

Drugs

EvaluationDrugModalityDoseRoute
Subject DKN-01 Monoclonal antibody 400 mg Intravenous
Background Bevacizumab Monoclonal antibody 5 mg Intravenous
Background Irinotecan Small molecule — Intravenous
Background Leucovorin Small molecule — Intravenous
Background Oxaliplatin Small molecule — Intravenous
Background fluorouracil Small molecule — Intravenous

Indications

colorectal adenocarcinoma