West Cancer Center

COLON: METASTATIC: 1st Line: HARMONi-GI3

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

Title

Summit SMT112-3005 Colon Metastatic 1st Line

Study Title

Site Link

NCT07228832

Malignancy

Colorectal, colon, rectum, rectal

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st Line

Investigational Agent

Ivonescimab

Drug Class

PD-1+VEGF monoclonal antibody

Brad Somer, MD

Sponsor

Summit Therapeutics

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Patients with histologically or cytologically confirmed metastatic CRC
No prior systemic therapy for mCRC
ECOG PS 0-1
At least 1 measurable non-cerebral lesion
Microsatellite stable (MSS)
No known BRAF mutation
No GI obstruction
No prior immunotherapy for colorectal cancer
No history of IBD
Disease must be unresectable

Objective

Primary
- PFS
Secondary
- OS
- ORR
- Safety
- DOR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Adenocarcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes