Study Comparing Petosemtamab Plus Chemotherapy to Cetuximab Plus Chemotherapy for Left-sided Colorectal Cancer
Sponsor: Genmab
ClinicalTrials ID:NCT07702032
This clinical trial is testing whether a new drug, petosemtamab, combined with chemotherapy, is more effective than the standard treatment for colorectal cancer on the left side of the colon that cannot be surgically removed or has spread.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The trial aims to find out how well petosemtamab, when combined with chemotherapy, works against colorectal cancer located on the left side of the colon that cannot be removed by surgery or has spread to other parts of the body. Participants will receive either petosemtamab with chemotherapy or the standard treatment, cetuximab with chemotherapy. The study will not use a placebo. Participants will have regular clinic visits for tests and procedures to monitor the treatment's safety and effectiveness. The length of the study will vary for each participant.
Description
This Phase 3 study is designed to compare the effectiveness and safety of petosemtamab combined with chemotherapy (either mFOLFOX6 or FOLFIRI) against the standard treatment of cetuximab with chemotherapy for patients with left-sided colorectal cancer that cannot be surgically removed or has spread. Participants will be randomly assigned to one of the treatment groups and will continue receiving the study treatment as long as it is effective and safe. Regular visits to the study clinic will include tests and procedures to check the treatment's impact on the cancer and the participant's health. The overall duration of the study, including screening, treatment, and follow-up, will differ for each participant.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with left-sided colorectal cancer that cannot be surgically removed or has spread.
- Cancer must be of a specific type (KRAS and NRAS wild type) as confirmed by specific genetic tests.
- No previous treatment with systemic therapy for this type of cancer.
- Eligible to receive specific chemotherapy treatments (mFOLFOX6 or FOLFIRI) based on local guidelines.
Exclusion Criteria
- Cancer has a BRAF mutation or specific genetic instability (MSI-H/dMMR).
- Previous treatment with drugs targeting the epidermal growth factor receptor (EGFR).
- Known deficiency in a specific enzyme (DPD) or genetic variants affecting this enzyme.
- For those receiving FOLFIRI: specific genetic markers related to UGT1A1.
- Have a type of cancer other than colorectal adenocarcinoma.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Vista Oncology | 98502 | Olympia | Washington |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.