Tovecimig + FOLFIRI for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments for individuals with advanced or metastatic colorectal cancer who have already tried one other treatment. It aims to determine if adding Tovecimig, a potential new drug, to a standard chemotherapy regimen (FOLFIRI) is safe and effective. The trial seeks participants whose cancer has progressed after initial therapy and who have undergone surgery to remove their primary tumor. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that FOLFIRI, a combination of chemotherapy drugs including Irinotecan, 5-Fluorouracil (5-FU), and Leucovorin, is commonly used to treat advanced colorectal cancer. Studies have found that some patients may experience side effects such as nausea, vomiting, and diarrhea. These side effects are common but can sometimes lead to discontinuing the treatment.
Tovecimig is a newer treatment being tested with FOLFIRI. Although limited safety information on Tovecimig exists, its inclusion in a Phase 2 trial indicates that early tests have deemed it safe enough for further research. This phase often evaluates how well patients tolerate the treatment and what side effects might occur.
Prospective trial participants should discuss their health and any concerns with their doctor. The doctor can explain how these treatments might affect them personally.12345Why are researchers excited about this trial's treatments?
Unlike the standard of care for colorectal cancer, which typically involves chemotherapy regimens like FOLFIRI, Tovecimig is a unique addition because it targets specific cancer cell pathways. Tovecimig works by honing in on and disrupting processes within cancer cells that allow them to grow and divide, potentially enhancing the effectiveness of the traditional chemotherapy drugs, 5-Fluorouracil and Irinotecan. Researchers are excited because this targeted approach could improve treatment outcomes and reduce side effects by sparing healthy cells, offering a more precise and potentially more effective option for patients.
What evidence suggests that Tovecimig combined with FOLFIRI could be an effective treatment for colorectal cancer?
Research has shown that combining Tovecimig with FOLFIRI may help treat advanced colorectal cancer. One study found that FOLFIRI alone had a response rate of 7.1% in similar cancer cases. However, adding other drugs to FOLFIRI, such as Bevacizumab, has slowed cancer growth and improved patient outcomes. In this trial, participants will receive Tovecimig with the FOLFIRI regimen. Early reports suggest that adding Tovecimig to FOLFIRI could enhance these positive effects. Overall, these findings indicate that Tovecimig with FOLFIRI might be a promising treatment option for patients with advanced colorectal cancer.12346
Who Is on the Research Team?
Olivia Aranha, MD, PhD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic colorectal cancer who have already tried one previous treatment. Participants should be healthy enough for more therapy and meet specific health requirements set by the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Tovecimig combined with FOLFIRI in 28-day cycles, with administration on Day 1 and 15 of each cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- 5-Fluorouracil (5-FU)
- Irinotecan
- Leucovorin
- Tovecimig
Trial Overview
The study tests a new drug, Tovecimig, given together with standard chemotherapy drugs (FOLFIRI: leucovorin, irinotecan, and 5-fluorouracil) to see if this combination works better as a second-line treatment. All participants know which treatments they receive.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Treatment will be administered in 28-day cycles. On Day 1 and 15 of each cycle, patients will receive Tovecimig followed by the FOLFIRI regimen.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Compass Therapeutics
Industry Sponsor
Citations
Effect of an Irinotencan, 5-Fluorouracil, and Leucovorin ...
The objective response rate of FOLFIRI was 7.1% in metastatic colorectal cancers. Nausea, vomiting, and diarrhea were the main causes of intolerance to the ...
2.
ascopost.com
ascopost.com/issues/march-1-2013/folfoxiribevacizumab-is-superior-to-folfiribevacizumab-in-mcrc/FOLFOXIRI Plus Bevacizumab Is Superior to FOLFIRI ...
At a median follow-up of 26.6 months, FOLFOXIRI/bevacizumab reduced the risk of progression by 27% (P = .0012), a benefit consistently seen ...
3.
2minutemedicine.com
2minutemedicine.com/fluorouracil-leucovorin-and-irinotecan-plus-panitumumab-for-the-treatment-of-metastatic-colorectal-cancer/Fluorouracil, leucovorin and irinotecan plus panitumumab ...
Overall, this study found that an intermittent strategy with FOLFIRI plus PAN is feasible and shows reduced toxicity while allowing patients ...
Tovecimig Plus FOLFIRI in Second Line Metastatic ...
This is an open-label Phase 2 study to evaluate the safety and efficacy of Tovecimig combined with FOLFIRI in patients who have received one prior line of ...
Evolution in the treatment of metastatic colorectal carcinoma of ...
These drugs had been shown to prolong disease free survival, with a large meta-analysis demonstrating a response rate of 32% and a median survival of 11.5 mo.
A retrospective observational study on the safety and efficacy ...
Forty-one patients (43.2%) received between 3 and 9 cycles of bevacizumab+FOLFIRI, 42 patients (44.2%) between 10 and 20 cycles, and 12 patients ...
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