INCB099280 for Cancer

Recruiting at 43 trial locations

Overseen By Incyte Corporation Call Center (US)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: Anticancer, Investigational, Probiotics, Antibiotics

Disqualifiers: Cardiac disease, Brain metastases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 3 months

182 Participants Needed

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

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.

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.

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

Group I: Cohort 3 Experimental Treatment 1 Intervention

Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy

Group II: Cohort 2 Experimental Treatment 1 Intervention

Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.

Group III: Cohort 1 Experimental Treatment 1 Intervention

Participants with select solid tumors who are immunotherapy treatment-naive

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

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