A Randomized, Open-label, Phase 3 Trial of Petosemtamab in Combination With mFOLFOX6 or FOLFIRI Versus Cetuximab in Combination With mFOLFOX6 or FOLFIRI as First-line Treatment for Participants With RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-525883-17-00

Enrollment

159

Registered

2026-10-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-10-20

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

Conditions

Colorectal Cancer

Brief summary

PFS per RECIST v1.1 as assessed by BICR, ORR per RECIST v1.1 as assessed by BICR

Detailed description

OS, DOR per RECIST v1.1 as assessed by BICR, DCR per RECIST v1.1, as assessed by BICR, PFS2, Curative resection (R0) rate, Incidence of AEs, Change from baseline and time to worsening in symptoms and functioning, as measured by EORTC QLQ-F17 and EORTC QLQ-CR29, Treatment group differences in overall side effect burden, as measured by EORTC Item 168.

Interventions

DRUGPetosemtamab

DRUGFolinic acid (as calcium folinate) 10 mg/ml solution for injection or infusion

DRUGIrinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion

DRUGOxaliplatin 5mg/ml Concentrate for Solution for Infusion

DRUGFluorouracil 50 mg/ml Solution for Injection or Infusion

DRUGErbitux 5 mg/mL solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS per RECIST v1.1 as assessed by BICR, ORR per RECIST v1.1 as assessed by BICR	—

Secondary

Measure	Time frame
OS, DOR per RECIST v1.1 as assessed by BICR, DCR per RECIST v1.1, as assessed by BICR, PFS2, Curative resection (R0) rate, Incidence of AEs, Change from baseline and time to worsening in symptoms and functioning, as measured by EORTC QLQ-F17 and EORTC QLQ-CR29, Treatment group differences in overall side effect burden, as measured by EORTC Item 168.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 21, 2026