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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 25 months
Awards & highlights
Study Summary
This trial will study a new drug 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've had disease progression after standard treatments or can't tolerate them. They should have a life expectancy over 12 weeks, be in fairly good health (ECOG score of 0-1), and have measurable lesions. Participants must not be pregnant or fathering children.Check my eligibility
What is being tested?
The study tests INCB099318's safety, how well it's tolerated, its pharmacokinetics (how the body processes the drug), and pharmacodynamics (the drug's effects on the body) in patients with various types of advanced solid tumors.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 cancer is advanced, can't be removed by surgery, and has measurable growths.
Select...
My condition worsened after treatment, or I can't tolerate/qualify for standard treatment.
Select...
I am fully active or can carry out light work.
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
Number of treatment-emergent adverse events
Secondary outcome measures
AUC0-t of INCB099318
CL/F of INCB099318
Cmax of INCB099318
+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
364 Previous Clinical Trials
55,060 Total Patients Enrolled
Louis Viviers, MDStudy DirectorIncyte Corporation
1 Previous Clinical Trials
203 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have untreated or worsening brain metastases.I am currently on medication for an infection.I am not taking probiotics during the study or screening.I have or am at risk for hepatitis B or C reactivation.I have a serious heart condition.You have a history of heart rhythm problems that the doctor thinks are important.I haven't taken any antibiotics in the last 28 days.I have another cancer that is getting worse or needs treatment.My cancer is advanced, can't be removed by surgery, and has measurable growths.Your lab test results are not within the specified ranges outlined in the study guidelines.My condition worsened after treatment, or I can't tolerate/qualify for standard treatment.I have been diagnosed with HIV.I still have side effects from previous treatments that are not mild.I have previously received anti-PD-L1 therapy.I am fully active or can carry out light work.I haven't taken any cancer drugs or experimental medications recently.You are expected to live for more than 12 weeks.
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 have the outcomes been regarding the safety of INCB099318 for those utilizing it?
"Based on our team's assessment, INCB099318 was given a rating of 1 due to its Phase 1 status meaning there is minimal data that supports the drug's safety and efficacy."
Answered by AI
Is this multidisciplinary research project seeking participants?
"Affirmative. According to the information on clinicaltrials.gov, this trial is currently recruiting patients; it was initially posted on March 26th 2021 and most recently edited on October 19th 2022. The study seeks to enrol 140 individuals across 3 medical centres."
Answered by AI
How many participants are engaged in this research?
"Indeed, the information found on clinicaltrials.gov indicates that this medical trial is in active recruitment stage. It was initially published on March 26th 2021 and modified most recently on October 19th 2022. The study requires 140 participants from 3 sites to be enrolled."
Answered by AI
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