Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)
Condition(s) studied
Investigational drug(s) / intervention(s)
Petosemtamab: Intravenous infusion
Cetuximab: Intravenous infusion
FOLFIRI: Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
mFOLFOX6: Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.
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.
Eligibility
Primary outcome measure(s)
- Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR) — Up to approximately 35 months
- Objective Response Rate (ORR) per RECIST v1.1 as Assessed by BICR — Up to approximately 35 months
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Genesis Cancer Center | Hot Springs | Arkansas | Recruiting |
| Valkyrie Clinical Trials - Los Angeles | Los Angeles | California | Recruiting |
| Low Country Cancer Care Associates_Savannah_1 | Savannah | Georgia | Recruiting |
| Central Georgia Cancer Care - Warner Robins Office | Warner Robins | Georgia | Recruiting |
| Hematology-Oncology of Indiana, P.C. | Indianapolis | Indiana | Recruiting |
| Oncology Hematology Associates - Springfield_Springfield_2 | Springfield | Missouri | Recruiting |
| Washington University Saint Louis | St Louis | Missouri | Recruiting |
| New York Cancer and Blood Specialists - Babylon Medical Oncology | Babylon | New York | Recruiting |
| Vista Oncology | Olympia | Washington | Recruiting |
| GenesisCare - Campbelltown CAMPBELLTOWN | Campbelltown | New South Wales | Recruiting |
| GenesisCare - St Andrew's ADELAIDE | Adelaide | South Australia | Recruiting |
| PanOncology | Manati | PR | Recruiting |
More Genmab trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07702032 on ClinicalTrials.gov ↗ ← All trials in the USA