182 Participants Needed

INCB099280 for Cancer

Recruiting at 43 trial locations
IC
IC
Overseen ByIncyte Corporation Call Center (US)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called INCB099280 to see if it is safe and effective for patients with certain types of solid tumors. Researchers want to understand how the drug behaves in the body and its early effects on cancer.

Do I need to stop my current medications to join the trial?

The trial requires a 28-day period without taking systemic antibiotics before starting the study drug. Probiotics are not allowed during the study and screening. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

Research Team

IM

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Eligibility Criteria

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.

Inclusion Criteria

My condition worsened after treatment, or I can't tolerate/qualify for standard treatment.
Life expectancy > 12 weeks.
I am fully active or restricted in physically strenuous activity but can do light work.
See 2 more

Exclusion 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.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INCB099280 to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics

Up to approximately 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 25 months

Treatment Details

Interventions

  • INCB099280
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

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