Study of Petosemtamab Plus Chemotherapy Versus Standard Treatments for Certain Types of Colorectal Cancer
Sponsor: Genmab
ClinicalTrials ID:NCT07775287
This clinical trial is comparing a new treatment using petosemtamab with chemotherapy against standard treatments for colorectal cancer that has returned, cannot be surgically removed, or has spread to other parts of the body.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to see how well a new treatment, petosemtamab combined with chemotherapy, works for colorectal cancer that has come back after treatment, cannot be removed by surgery, or has spread. Participants will receive either petosemtamab with chemotherapy or a standard treatment chosen by their doctor, which includes cetuximab or bevacizumab with chemotherapy. No one will receive a placebo. The length of treatment will vary for each person, and they can continue as long as the cancer does not worsen and there are no serious side effects. Participants will visit the clinic twice every four weeks for tests and procedures to check the safety and effectiveness of the treatment. The total duration of the study, including screening, treatment, and follow-up, will differ for each participant.
Description
This Phase 3 study is being conducted globally to compare the effectiveness and safety of petosemtamab with chemotherapy against standard treatments for colorectal cancer that is recurrent, cannot be surgically removed, or has spread. Participants will be randomly assigned to one of two groups: one group will receive petosemtamab with chemotherapy (FOLFIRI or mFOLFOX6), and the other group will receive standard treatment with cetuximab or bevacizumab plus chemotherapy. The study will help determine which treatment is more effective as a second-line option for patients with specific genetic types of colorectal cancer.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of colorectal cancer that has returned, cannot be surgically removed, or has spread.
- Must have specific genetic markers (KRAS and NRAS wild type) as shown by test results.
- Have received no more than one previous treatment for cancer that cannot be removed or has spread, with documented progression.
- Be eligible for treatment with specific chemotherapy regimens (mFOLFOX6 or FOLFIRI) based on local guidelines.
Exclusion Criteria
- Have a specific BRAF mutation or other genetic markers that exclude participation.
- Have previously been treated with drugs targeting the epidermal growth factor receptor (EGFR).
- Have previously received irinotecan or oxaliplatin in the metastatic setting.
- Have a known deficiency in certain enzymes (DPD or UGT1A1) that affect drug metabolism.
- Have a type of cancer that is not colorectal adenocarcinoma.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Valkyrie Clinical Trials - Los Angeles | 90067 | Los Angeles | California |
| Low Country Cancer Care Associates_Savannah_2 | 31404 | Savannah | Georgia |
| Vista Oncology - West Olympia_Olympia_2 | 98502 | Olympia | Washington |
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