INCB177054 + Retifanlimab for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called INCB177054, both alone and with retifanlimab (an immunotherapy), to determine their effectiveness in treating advanced solid tumors. Researchers aim to find the right doses and assess how well these drugs work together. The trial targets individuals with solid tumors, such as certain head and neck cancers or advanced lung cancer, that do not respond to standard treatments. Participants should have a solid tumor that has worsened despite previous treatments and cannot be cured with surgery. Those experiencing frequent tumor progression or who have exhausted all other treatments might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial protocol does not clearly specify if you must stop taking your current medications. However, it mentions that you should not have taken anticancer medications or investigational drugs within 28 days before starting the study drug, and certain medications may be prohibited. 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 is examining the safety and tolerability of INCB177054 and its combination with retifanlimab for treating advanced or spreading solid tumors. Although specific results from human trials are not provided, these studies aim to understand the side effects and determine the safest doses.
Retifanlimab, part of the combination treatment, has demonstrated positive safety results in other studies. It is often used with other drugs, indicating general tolerability. The current studies focus on ensuring these treatments are safe for participants by carefully adjusting doses and monitoring for side effects. This approach helps identify any negative effects early in the testing process.12345Why are researchers excited about this trial's treatments?
Researchers are excited about INCB177054 and Retifanlimab because these treatments offer a novel approach to tackling solid tumors. Unlike traditional chemotherapy, which targets rapidly dividing cells, INCB177054 works by a different mechanism, potentially interfering with cancer cell signaling pathways. Retifanlimab, on the other hand, is an immunotherapy drug that helps the immune system recognize and attack cancer cells, offering a targeted approach to treatment. The combination of these therapies could enhance effectiveness by both disrupting cancer cell growth and boosting the body's natural defenses, providing hope for better outcomes in patients with solid tumors.
What evidence suggests that this trial's treatments could be effective for solid tumors?
Research has shown that INCB177054, a new treatment under study in this trial, can significantly shrink tumors by targeting specific enzymes in cancer cells. This makes it a promising option for treating advanced solid tumors. In this trial, some participants will receive INCB177054 alone, while others will receive it with Retifanlimab. Retifanlimab, when used with INCB177054, has effectively treated tumors that respond well to PD-1 inhibitors, such as melanoma and non-small cell lung cancer. Earlier studies demonstrated that retifanlimab helped patients live longer without disease progression. Together, these treatments aim to enhance the immune system's ability to fight cancer, offering hope for better outcomes in solid tumor cases.12346
Who Is on the Research Team?
Incyte Medical Monitor
Principal Investigator
Incyte Corporation
Are You a Good Fit for This Trial?
This trial is for adults with certain advanced or metastatic solid tumors, including uterine and other specific tumor locations. Participants must have a life expectancy over 12 weeks, be in good physical condition (ECOG score of 0-1), and have progressed after standard treatments or are unable to tolerate them. Specific groups include those suitable for immunotherapy and those with particular types of head, neck, lung cancer.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive INCB177054 as monotherapy or in combination with retifanlimab, with dose escalation and expansion phases
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-emergent adverse events and disease response
What Are the Treatments Tested in This Trial?
Interventions
- INCB177054
- Retifanlimab
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