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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.
Eastern Cooperative Oncology Group performance status score of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 25 months
Awards & highlights
Study Summary
This trial is testing a new drug, INCB099280, to see if it is safe and effective in treating solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors who have tried all other treatments without success or can't tolerate them. They should be relatively healthy otherwise, able to perform daily activities with ease (ECOG score of 0-1), and not planning to conceive. People with heart issues, untreated brain metastases, active infections, or recent use of certain drugs can't join.Check my eligibility
What is being tested?
INCB099280 is being tested in this study. The goal is to see how safe it is for patients and how their bodies handle the drug (pharmacokinetics). Researchers also want to understand how the drug affects tumor biology (pharmacodynamics) and if it shows any signs of fighting the cancer.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at the injection site, fatigue, nausea, changes in blood counts or chemistry that could affect organ function. Side effects will be closely monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition worsened after treatment, or I can't tolerate/qualify for standard treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My advanced cancer can't be removed by surgery and has measurable growths.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 25 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 25 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Secondary outcome measures
AUC0-t of INCB099280
CL/F of INCB099280
Cmax of INCB099280
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy
Group II: Cohort 2Experimental Treatment1 Intervention
Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.
Group III: Cohort 1Experimental Treatment1 Intervention
Participants with select solid tumors who are immunotherapy treatment-naive
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
365 Previous Clinical Trials
54,986 Total Patients Enrolled
Louis Viviers, MDStudy DirectorIncyte Corporation
1 Previous Clinical Trials
105 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
23 Previous Clinical Trials
4,869 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious heart condition.I have untreated or worsening brain metastases.I haven't taken any cancer drugs or experimental medications recently.I have previously received anti-PD-L1 therapy.My condition worsened after treatment, or I can't tolerate/qualify for standard treatment.I have or am at risk for hepatitis B or C reactivation.I am currently on medication for an infection.You have a history of heart rhythm problems that the doctor thinks are important.I am fully active or restricted in physically strenuous activity but can do light work.Your lab test results are not within the specified ranges in the study guidelines.I am not taking probiotics and will not while in the study.I have been diagnosed with HIV.I have another cancer that is getting worse or needs treatment.My advanced cancer can't be removed by surgery and has measurable growths.I still have side effects from previous treatments that are not mild.I have not taken any antibiotics in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
- Group 3: Cohort 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current status of INCB099280 approval from the Federal Drug Administration?
"Since INCB099280 is in Phase 1 of the clinical trial process, its safety has been assessed as a score of 1 on our scale due to limited data supporting both efficacy and safety."
Answered by AI
Is the enrollment period of this research still ongoing?
"This trial, which was initially listed on September 4th 2020 and most recently updated November 7th 2022, is actively seeking participants per clinicaltrials.gov."
Answered by AI
What is the approximate size of this clinical investigation?
"Affirmative. Clinicaltrials.gov contains data which shows that this study, first posted on September 4th 2020, is actively enrolling volunteers for participation. A total of 203 individuals need to be sourced from 3 different medical centres."
Answered by AI
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