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Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer

NCT07702032 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 960

Last updated 2026-08-04

No results posted yet for this study

Summary

The purpose of this trial is to evaluate how well petosemtamab in combination with chemotherapy works against colorectal cancer located on the left side of the colon that cannot be safely removed by surgery or has spread to other parts of the body.

Participants will receive either petosemtamab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI) or standard-of-care cetuximab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI). No participants will be given placebo.

The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.

Participants will be asked to attend 2 visits at the study clinic for each cycle (duration of cycle is 4 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) will be different for every participant.

Conditions

  • Left-sided Colorectal Cancer

Interventions

DRUG

Petosemtamab

Intravenous infusion

DRUG

Cetuximab

Intravenous infusion

DRUG

FOLFIRI

Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.

DRUG

mFOLFOX6

Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.

Sponsors & Collaborators

Principal Investigators

  • Study Official · Genmab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2029-07-31
Completion
2031-09-30
FDA Drug
Yes

Countries

  • Puerto Rico

Study Locations

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Entities

Drugs
Companies

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 NCT07702032 on ClinicalTrials.gov