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INCB099280 for Cancer

Phase 1
Recruiting
Research Sponsored by Incyte Corporation
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 below
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My condition worsened after treatment, or I can't tolerate/qualify for standard treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My advanced cancer can't be removed by surgery and has measurable growths.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 25 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 25 months for reporting.

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 more

Trial 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
54,962 Total Patients Enrolled
Louis Viviers, MDStudy DirectorIncyte Corporation
1 Previous Clinical Trials
105 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
22 Previous Clinical Trials
4,845 Total Patients Enrolled

Media Library

INCB099280 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04242199 — Phase 1
Esophageal Cancer Research Study Groups: Cohort 1, Cohort 2, Cohort 3
Esophageal Cancer Clinical Trial 2023: INCB099280 Highlights & Side Effects. Trial Name: NCT04242199 — Phase 1
INCB099280 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04242199 — Phase 1

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
~52 spots leftby Jul 2025