A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521587-35-00

Enrollment

154

Registered

2026-02-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic colorectal cancer

Brief summary

PFS by IRRC based on RECIST v1.1

Detailed description

OS, ORR and DOR as assessed by IRRC based on RECIST v1.1, Safety assessment: incidence and severity of adverse events (AEs), clinically significant abnormal laboratory test results, Pharmacokinetic profile: Serum concentrations of ivonescimab in patients at different time points after ivonescimab administration, Immunogenicity assessment: Number and percentage of patients with detectable anti-ivonescimab antibody

Interventions

DRUGFLUOROURACIL

DRUGBEVACIZUMAB

DRUGFOLINIC ACID

DRUGOXALIPLATIN

DRUGivonescimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS by IRRC based on RECIST v1.1	—

Secondary

Measure	Time frame
OS, ORR and DOR as assessed by IRRC based on RECIST v1.1, Safety assessment: incidence and severity of adverse events (AEs), clinically significant abnormal laboratory test results, Pharmacokinetic profile: Serum concentrations of ivonescimab in patients at different time points after ivonescimab administration, Immunogenicity assessment: Number and percentage of patients with detectable anti-ivonescimab antibody	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 14, 2026