RO7198457 for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, RO7198457, for individuals with certain types of colorectal cancer completely removed by surgery. Researchers aim to determine if this treatment is more effective than the current standard approach of watchful waiting, particularly in patients with circulating tumor DNA (tiny pieces of cancer DNA in the blood). Individuals who have had Stage II or III rectal cancer or Stage II (high risk) or III colon cancer, with surgery that removed all cancer, and who have detectable tumor DNA in their blood, might be suitable for this trial. Participants will either receive the experimental treatment RO7198457 or undergo close monitoring without additional treatment. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on systemic immunosuppressive medication or have recently taken another investigational drug. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that RO7198457, whether used alone or with atezolizumab, is generally well-tolerated by patients with advanced tumors. In earlier studies, most patients experienced mild to moderate side effects, indicating that the side effects were usually not severe.
RO7198457 is still undergoing testing in mid-phase trials, meaning researchers continue to assess its safety. Its progression to this phase suggests it has passed initial safety checks, which may reassure those considering trial participation. Participants should always discuss potential risks and benefits with their healthcare provider.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for colorectal cancer, which often include chemotherapy and targeted therapies like bevacizumab or cetuximab, RO7198457 is unique because it leverages a personalized approach to target the cancer. Researchers are excited about this treatment because it utilizes a novel mechanism that tailors the therapy to the specific genetic makeup of the tumor. This personalized strategy has the potential to improve effectiveness and reduce side effects by precisely targeting cancer cells, offering a promising alternative to existing options.
What evidence suggests that RO7198457 might be an effective treatment for colorectal cancer?
Research has shown that RO7198457, a personalized mRNA vaccine, may help treat colorectal cancer. In earlier studies, patients who received RO7198457 experienced fewer recurrences of their tumors. The vaccine trains the immune system to identify and attack cancer cells by targeting proteins unique to each person's cancer. In this trial, some participants will receive RO7198457, while others will be part of an observational group undergoing standard watchful waiting. Early results suggest this method might be more effective than monitoring the condition alone in patients with high-risk colorectal cancer. Although more research is needed, the initial findings offer promise for those seeking new treatment options.678910
Who Is on the Research Team?
BioNTech Responsible Person
Principal Investigator
BioNTech SE
Are You a Good Fit for This Trial?
This trial is for adults with Stage II (high risk) or Stage III colorectal cancer that's been surgically removed and have detectable ctDNA. They must have started standard chemotherapy within 8 weeks post-surgery and completed at least 3 months of it. Exclusions include uncontrolled illnesses, prior certain treatments, unresolved toxicities from previous therapies (except hair loss and mild neuropathy), known allergies to RO7198457, recent major surgery, active hepatitis B/C, HIV positivity, or other current/past cancers with specific exceptions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 15 doses of RO7198457
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Observational group (no intervention)
- RO7198457
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioNTech SE
Lead Sponsor
Prof. Dr. Ugur Sahin
BioNTech SE
Chief Executive Officer since 2008
MD from University of Cologne
Prof. Özlem Türeci
BioNTech SE
Chief Medical Officer since 2018
MD from Saarland University
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD