A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents
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What is colorectal cancer?
Colorectal cancer starts in the colon or the rectum, the last sections of the digestive tract, almost always from a polyp that grows slowly over years before turning cancerous. That slow start is why screening works so well: a colonoscopy can remove polyps before they become cancer, and stool tests can catch early disease. About one in three cases is rectal cancer. Early colorectal cancer often has no symptoms; later signs include blood in the stool, a change in bowel habits lasting more than a few days, cramping, unexplained weight loss, and fatigue from anemia. Risk rises with age, with a family history or inherited syndromes such as Lynch syndrome, with inflammatory bowel disease, and with obesity, red and processed meat, alcohol, and smoking. The rise in younger adults has prompted research into diet, the gut microbiome, and antibiotics, but no single cause has been found.
Two facts shape what trials exist. First, stage matters enormously: five year survival is around 90 percent when the cancer is caught early and under 15 percent once it has spread widely, yet three in four cases in people under 50 are found at an advanced stage. That is why screening now starts at 45 rather than 50, and why blood based screening tests, the first of which the FDA approved in 2024, are being studied so closely. Second, colorectal cancer has become one of the most biomarker driven cancers: tumors are tested for KRAS, BRAF, HER2, and mismatch repair status, and each result opens different trials, from immunotherapy for mismatch repair deficient tumors to targeted drugs for specific mutations.
Our guide explains how clinical trials for cancer work.
Inherited colorectal cancer syndromes also raise the risk of pancreatic and ovarian cancer. Bowel symptoms with no cancer found are often irritable bowel syndrome, which has its own studies.
Types of colorectal cancer clinical trials
Advanced disease drug trials. Antibody drug conjugates, new targeted pills for KRAS and other mutations, and immunotherapy combinations for metastatic colorectal cancer, several in Phase 3.
Early stage and survivorship trials. Studies of what happens after surgery, including which patients need chemotherapy, and large trials of education and support programs for people treated for stage II or III disease.
Vaccine and cell therapy trials. Early phase studies of cancer vaccines and engineered immune cells aimed at proteins found on colorectal tumors.
Screening and early detection trials. Blood tests, stool tests, and outreach programs that bring screening to people who have never had it, often enrolling healthy adults 45 and older.
Young onset research. Studies specifically in adults diagnosed under 50, looking at causes, treatment response, and fertility and family concerns.
Hereditary risk studies. Genetic testing programs and surveillance for people with Lynch syndrome or a strong family history.
New to research? Read how informed consent works.
Who can participate in colorectal cancer clinical trials?
Treatment trials sort people by stage and biomarkers. Metastatic trials usually require a specific prior treatment history, for example progression after standard chemotherapy, and often a tumor test showing a target such as a KRAS mutation, HER2, or mismatch repair deficiency. Early stage trials enroll people around surgery. Screening trials enroll adults 45 and older with no diagnosis, and young onset studies enroll people diagnosed before 50 regardless of stage. Most require adequate organ function and the ability to manage daily activities. Eligibility always varies by study; our guide covers eligibility criteria.
What is the difference between colon cancer and rectal cancer?
They start in different parts of the large bowel, the colon or the final section, the rectum, and are treated somewhat differently: rectal cancer more often involves radiation before surgery. About one in three colorectal cancers is rectal, and rectal cancer is rising fastest in younger adults.
The stages of colorectal cancer, and why they matter for trials
Stage 0 and I. Confined to the inner layers of the bowel wall. Treated with surgery alone; five year survival around 90 percent. Few drug trials, many screening and surveillance studies.
Stage II and III. Grown through the wall or into nearby lymph nodes. Surgery, often with chemotherapy; rectal cancers may get radiation first. Trials test who needs chemotherapy and how to support recovery.
Stage IV. Spread to the liver, lungs, or elsewhere. Five year survival under 15 percent overall, though surgery on limited liver spread can still cure some people. Most new drug trials recruit here, sorted by biomarkers.
Study titles say "metastatic," "resectable," or "stage II/III," and increasingly name a biomarker. Your stage and your tumor's test results tell you which studies fit.
How to enroll in a colorectal cancer clinical trial
Identify your trial. Use the filters. Titles name the stage, line of treatment, and often a biomarker; screening studies say "screening" or "early detection."
Select your preferred location. Enter your city or state. Phase 3 drug trials run at many community oncology sites; vaccine and cell therapy trials at a few centers.
Explore study details. Click "Learn More" for biomarker requirements, prior treatments allowed, and the visit schedule.
Complete the health profile. Click "Get started" to begin the 5-step application. Have three things ready: your stage and whether it is colon or rectal cancer, your tumor biomarker results if tested, and the treatments you have had.
Submit the application. A clinical trial coordinator reviews it and contacts you. Nothing is decided until informed consent, and participation is voluntary at every step.