INCA33890 for Metastatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called INCA33890 for individuals with advanced or metastatic cancer, where the cancer has spread to different parts of the body. The main goal is to determine the safety of INCA33890 and identify the optimal dose, either alone or in combination with other cancer drugs like bevacizumab, cetuximab, FOLFOX, or FOLFIRI. This trial may suit those with solid tumors unresponsive to standard treatments or who cannot undergo them. Participants should be able to undergo tumor biopsies and have measurable disease for tracking. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic systemic steroids or have recently changed anticoagulation therapies, you may not be eligible to participate.
Is there any evidence suggesting that INCA33890 is likely to be safe for humans?
Research has shown that INCA33890 is being tested for treating advanced or spreading solid tumors. This treatment remains in early research stages, so limited safety information is available. Early results suggest that INCA33890, when used alone, has a manageable safety profile. Some patients have experienced tumor shrinkage or stabilization. However, specific side effects of INCA33890 alone are not detailed.
When combined with bevacizumab (a drug that inhibits blood vessel growth in tumors), the safety of INCA33890 is still under study. Bevacizumab can cause serious side effects like bleeding and stomach issues, but careful monitoring usually manages these.
The safety of INCA33890 is also being evaluated when used with chemotherapy treatments like FOLFOX and FOLFIRI (both chemotherapy combinations). These combinations can cause side effects from both the drugs and chemotherapy, often including tiredness, nausea, and a higher risk of infection.
Lastly, when used with cetuximab (another cancer treatment), INCA33890 has shown a manageable safety profile in early studies. Common side effects of cetuximab include skin reactions and low magnesium levels in the blood.
Overall, while INCA33890 appears promising, more information from ongoing studies is needed to fully understand its safety in humans. Clinical trial participants are closely monitored to manage any side effects that might occur.12345Why are researchers excited about this trial's treatments?
Researchers are excited about INCA33890 because it represents a novel approach for treating metastatic cancer. Unlike current standard treatments, which often include chemotherapy and targeted therapies like bevacizumab, FOLFOX, and FOLFIRI, INCA33890 offers a new mechanism of action. It is designed to be used both as a monotherapy and in combination with other established treatments, potentially enhancing their effectiveness. This flexibility could lead to more personalized treatment plans, offering hope for better outcomes in a condition that is notoriously difficult to treat.
What evidence suggests that this trial's treatments could be effective for metastatic cancer?
Research has shown that INCA33890 achieved a promising success rate of 15.2% in previous studies, with some patients experiencing a significant reduction in tumor size. In this trial, participants will receive INCA33890 in different treatment arms. One arm combines INCA33890 with bevacizumab, a current cancer drug, expected to enhance effectiveness since bevacizumab has been shown to extend patient survival and slow cancer growth. Other arms will explore INCA33890 with chemotherapy treatments like FOLFOX or FOLFIRI, known to improve outcomes in advanced cancer, potentially increasing its effectiveness. Another arm will combine INCA33890 with cetuximab, another cancer treatment, which is promising due to cetuximab's proven benefits in treating certain cancers. These combinations aim to fight cancer more effectively by attacking it in different ways.14567
Are You a Good Fit for This Trial?
Adults with certain advanced or metastatic solid tumors who've had disease progression after standard treatments, including immunotherapies if applicable. They must have a good performance status, measurable disease, and be willing to undergo tumor biopsies. Exclusions include significant medical conditions, more than four prior cancer treatments for advanced disease, active infections or hepatitis/HIV, recent anticoagulation therapy changes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
INCA33890 is administered intravenously at a starting regimen, with subsequent dose regimens determined during study conduct
Dose Expansion
INCA33890 is administered at the recommended dose(s) for expansion in participants with advanced or metastatic ICI sensitive or ICI non-sensitive tumor types
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- INCA33890
Find a Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School